idea-018 · human · active
For prescription home use by skeletally mature adults, to promote osteogenesis; at an established nonunion of a long bone fracture — excluding nonunions of the skull and; vertebrae and tumor-associated nonunions — in which serial radiographs confirm that fracture; healing has ceased for three or more months, as an adjunct to standard fracture management; not indicated for acceleration of healing of fresh or acute fractures, not indicated as an; adjunct to spinal fusion, and not indicated for skeletally immature patients.
| Mechanism | An externally worn, battery-powered coil applies a pulsed electromagnetic field; (PEMF) across the fracture gap of an established long-bone nonunion for a prescribed number; of hours per day over a fixed treatment course, with the aim of promoting osteogenesis at a; fracture that has stopped healing. The differentiating engineering is not the field: it is a; low-profile, garment-integrated coil sized to be worn under clothing, plus an onboard; tamper-evident treatment-time log that records actual field-on minutes against the; prescribed schedule and exports a compliance report for the prescriber and the DMEPOS; supplier's documentation file. |
|---|---|
| Device class | Class II — 510(k) — 21 CFR 890.5870, product code LOF (non-invasive bone growth; stimulator, electrical/magnetic) — launch route under the narrow intended use below.; Available only since the reclassification final order (FR document 2026-07366, published; 2026-04-16) took effect 2026-05-18. Special controls at 21 CFR 890.5870(b)(2) apply; the; Generator did not retrieve their text and does not assert what they require.; Class II — 510(k) — 21 CFR 890.5870, product code LPQ (ultrasonic variant) — the same; regulation and the same narrow indication, reached with low-intensity pulsed ultrasound; instead of a PEMF coil. Carried because it is a live engineering fork that changes the; reimbursement code (E0760 rather than E0747) without changing the regulation, not because; the Generator has chosen it.; Class III — PMA, 21 CFR Part 814 — NOT live under the current intended_use. This is; the route the same hardware sat on before 2026-05-18, and the route the Generator expects; an indication written wider than 890.5870's own indication language — acceleration of; healing of fresh fractures, or general osteogenesis — would still face, since such an; indication falls outside the reclassified generic type. The Generator did not identify; a regulation or product code FDA would assign to that broader claim and is not asserting; one; a De Novo under section 513(f)(2) is an alternative that was not ruled out. The; narrowing away from this route is the whole idea of this candidate. |
| Predicate or analog | No 510(k) cleared under 21 CFR 890.5870 was identified by the Generator; as of 2026-09-18 — the regulation has only been in force since 2026-05-18, so a cleared-under-; Class-II predicate may not yet exist. The closest analogs are the legally marketed; pre-reclassification devices: Orthofix "Physio-Stim" and "Spinal-Stim", Zimmer Biomet; "OrthoPak", and Bioventus "EXOGEN" (ultrasonic). The Generator did not retrieve a PMA; number or a K-number for any of these and is not asserting one. Whether a device legally; marketed under a PMA before the reclassification is available as a 510(k) predicate; afterwards is a Generator inference, written as a claim below and unverified. |
| Launch jurisdiction | US |
| Target | human |
Read this before anything else on the page. A low count here is usually a
statement about this repo's tooling rather than about the idea — a
unconfirmed reimbursement claim most often means the CMS cache file
is absent and nothing was searched, which is not evidence that a code
does not exist.
The coverage above says how much is known. This says what any of it is for: the propositions this opportunity rests on, ordered by what a failure would cost and, inside that, by what settling it would take. Derived from the pillars and the claims' current tags, not written.
This packet is unassessed. Its claims carry tags, so the file says how sure anybody is about each one — and nothing says which of them the idea actually rests on, or what it would cost to be wrong about one. Run /assess idea-018 to add that. Unassessed is a state, not a failing score.
The packet a human reads. See docs/wrap-spec.md. This section says nothing about whether the idea is good — it says the file is finished enough to be read, and names what to do next. Filling it in advances no candidate and approves nothing.
The one-paragraph version.
What would have to be true.
Cheapest next test:
Where the evidence actually stands.
| Factor | Score | Why | What would settle it |
|---|---|---|---|
| Regulatory pathway | 3 | intended_use is stated, so this is scorable. Claims 1, 2, 5, 6 — if they hold, the launch route is Class II 510(k) under 21 CFR 890.5870, live since 2026-05-18, and claim 7's narrowing inference keeps the indication inside the…the rest of this reasoningregulation's own language. Discounted from a 4 by claim 20 (no 510(k) cleared under 890.5870 was found, and no search was run) — a 510(k) with no predicate is not the cheap pathway this candidate is built on — and by claim 3 (special-controls text never retrieved, so the evidence burden is unknown). Claim 4's six-year proposed-to-final gap is a settledness signal, unchecked. | openFDA clearances query on product codes LOF and LPQ with a decision-date window from 2026-05-18, to establish whether any predicate exists — cheap, and it is the first check. Then the eCFR text of 890.5870(b)(2) for the special controls;…the rest of this gap analysisthe claim-7 inference really needs an FDA pre-submission, not a lookup. |
| Reimbursement pathway | 4 | Claims 8, 9, 10, 13, 23 — if they hold, this is national coverage under NCD 150.2 with an existing HCPCS code (E0747), an indication deliberately written to restate the NCD's radiographic nonunion definition, and separate DMEPOS payment.…the rest of this reasoningStrongest factor in the file. Held off 5 because claim 16 (price) is an unsourced guess, so the code's existence is not yet a demonstration it pays above cost, and claim 12's policy article A52513 was never opened, so documentation/coverage conditions are unknown. Claim 22 records that the RAPID coverage-at-authorization lane is forgone. | CMS Medicare Coverage Database record for NCD 150.2 (version and effective date) and LCA A52513; HCPCS quarterly release file for the E0747 descriptor. All free web lookups. |
| TAM | 2 | Claims 15, 16, 17 — all three legs are explicitly the Generator's unsourced guesses, so this score is what they would imply, not a finding. Low tens of thousands of E0747 services at low-thousands each puts the US Medicare line in the…the rest of this reasoningtens of millions: above the 2/5 floor if true, but small, and the narrowing shrinks it on purpose (claim 17's denominator, claim 18's forgone E0748 line). The relative-size half of claim 18 is flagged as belief, not data. | CMS DMEPOS utilization public-use file for E0747 allowed services (pull E0748 in the same query to settle claim 18); DMEPOS fee schedule PUF for the purchase allowance. Both free; this is the cheapest high-value check in the file. |
| FTO / IP | 2 | Claims 26 and 27: no patent search of any kind was performed and no patent number, family or expiry date is named. Scored as unknown-leaning-neutral for triage only. Claim 27's "1970s-80s PEMF art would be expired" is explicitly an…the rest of this reasoninginference about a class of patents, not a finding, and it says nothing about the modern differentiators — garment-integrated coil geometry and tamper-evident adherence logging — where live art is most likely. Unexamined is not clear; the Stage 5 FTO kill cannot fire on this. | A PatentsView or EPO OPS assignee search against Orthofix, Zimmer Biomet, Bioventus and Enovis, plus a CPC search on the adherence-logging function. A few hours of analyst time; a real clearance opinion is a paid counsel job. |
| Moat / defensibility | 1 | Claim 21 is decisive and points down: the 510(k) door opened for every incumbent and entrant on the same day, so the pathway confers no exclusivity. That leaves only the special controls' evidence bar (claim 3, content unknown), DMEPOS…the rest of this reasoningmachinery, and the adherence log — whose entire commercial case is claim 30, an explicit assumption, reinforced by claims 28 and 29 (prescriber preference and patient adherence, both assumptions with no source). | Nothing here is settleable by a connector. Read LCA A52513 to see whether device-generated adherence records carry documentation weight, then commission prescriber and DMEPOS-supplier interviews — a paid primary-research line item, not a…the rest of this gap analysislookup. |
| Mechanism & clinical risk | 2 | Mechanism plausibility is helped by the class having been marketed for decades (claims 5, 19), but the indication-specific evidence is a named hole: claim 25 records that no literature on PEMF in established nonunion was retrieved in…the rest of this reasoningeither direction. Claim 24 pulls down — the TRUST LIPUS trial is recalled as negative in the adjacent fresh-fracture setting — and is itself only the Generator's recollection with no PMID, so it is a search handle, not a citation. | A PubMed sweep on PEMF and electrical stimulation in established nonunion, and retrieval of the TRUST trial's PMID to confirm design and result. Free, a few hours. |
| Capital intensity & time-to-revenue | 3 | If claims 1, 2, 5 and 13 hold, this is commodity hardware onto an existing pathway and an existing payment code — fast and cheap by medtech standards. Held at 3 because the two unknowns that set the actual cost both sit on unexamined…the rest of this reasoningclaims: no predicate found (claim 20) and special-controls content unretrieved (claim 3), either of which could turn a 510(k) into a De Novo-scale evidence programme. Claim 22 removes the RAPID lane. | Falls out of the Regulatory checks above — the openFDA LOF/LPQ predicate query and the 890.5870(b)(2) special-controls text. No separate work. |
| Competitive intensity | 1 | Claim 19 names four entrenched incumbents (Orthofix, Zimmer Biomet, Bioventus, plus Enovis at claim 27) with established DMEPOS distribution, and claim 21 says they all gained the same cheap route on the same day. Claim 28 records…the rest of this reasoningprescriber preference for incumbent brands as an assumption working against a new entrant. No funding, launch or recall data was retrieved for any of them. | openFDA device recall/enforcement records and 510(k) filings for the named assignees, plus a public-filings or press sweep on recent launches. Free and quick; a licensed market report would be a paid attachment a human must supply. |
| Strategic fit & portfolio balance | — | Left unscored. No claim in this file speaks to portfolio fit — there is no orthopedic/nonunion dossier in knowledge-base/domains/ (see domains: in frontmatter) and nothing records what the current portfolio holds. Scoring this…the rest of this reasoningwould mean inventing the comparison, so the row stays blank rather than guessed. | A human or the Librarian naming the current portfolio position this would occupy (cash-generative spoke vs. hero bet). No external source; internal context this candidate has not been given. |
To finish this packet:
domains: — run /researchDomain dossier: none linked
Source file: knowledge-base/candidates/idea-018.md
Nothing on this page is a recommendation. Shortlist review, legal and clinical sign-off and capital allocation are human-only decisions, and no agent in this repo may make or simulate one. This is a compilation of what the candidate file says.