Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp.
Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. (Indiana): 510(k) cleared for OrthoPediatrics Corp. Its amount of 154 is above the median of 138 (57th percentile). Dated 41 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 154 · 57th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 12 related IN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261345 |
| Device | Pediatric Nailing Platform Femur |
| Applicant | OrthoPediatrics Corp. |
| Specialty / panel | Orthopedic |
| Product code | HSB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-23 |
| Decision date | 2026-09-24 |
| Review time (days) | 154 |
| Third-party review | No |
| Applicant location | Warsaw, IN, US |
| amount percentile | 57th of 414 (median 138, 1.1x median) |
| Peer records CSV (13 IN records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-24
- Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. and 13 Indiana peers
- Indiana FDAPulse records like this one: 13
- Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp.'s amount: 57th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Indiana peer: $2,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 154-day review, longer than typical.
- Posted 41 days ago.
What is the FDAPulse record for Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. in Indiana?
Pediatric Nailing Platform Femur (K261345) by OrthoPediatrics Corp. was cleared on 2026-09-24 after 154 days of review.
How does Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. compare to other Indiana FDAPulse records?
Its amount of 154 sits in the upper half (57th percentile) of 414 records; the median is 138. It is 41 days old, still within a typical 45-day follow-up window.
Pediatric Nailing Platform Femur (K261345) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Pediatric Nailing Platform Femur (K261345) | IN | 2026-09-24 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
Related records
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
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- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
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