Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd.
Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd.: 510(k) cleared for Corin, Ltd. Its amount of 153 is above the median of 138 (56th percentile). Dated 48 days ago, it serves as a historical benchmark. Score 42/100. 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: 153 · 56th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 7 related GB FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261275 |
| Device | Unity Total Knee System, Unity Knee Cementless CR Femur |
| Applicant | Corin, Ltd. |
| Specialty / panel | Orthopedic |
| Product code | MBH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-17 |
| Decision date | 2026-09-17 |
| Review time (days) | 153 |
| Third-party review | No |
| Applicant location | Cirencester, GB |
| amount percentile | 56th of 414 (median 138, 1.1x median) |
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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: 2026-09-17
- 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: Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd. and 8 GB peers
- GB FDAPulse records like this one: 8
- Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd.'s amount: 56th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every GB peer: $1,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 153-day review, longer than typical.
What is the FDAPulse record for Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd.?
Unity Total Knee System, Unity Knee Cementless CR Femur (K261275) by Corin, Ltd. was cleared on 2026-09-17 after 153 days of review.
How does Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd. compare to other FDAPulse records?
Its amount of 153 sits in the upper half (56th percentile) of 414 records; the median is 138. It is 48 days old; check the official source for later updates before acting.
Unity Total Knee System, Unity Knee Cementless CR Femur (K261275) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Unity Total Knee System, Unity Knee Cementless CR Femur (K261275) | GB | 2026-09-17 |
| 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 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Orthopedic devices
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