G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet
G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet (Indiana): 510(k) cleared for Zimmer Biomet. Its amount of 145 is above the median of 138 (54th percentile). Dated 42 days ago, it serves as a historical benchmark. Score 36/100. 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: 145 · 54th 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 | K261453 |
| Device | G7® Acetabular System |
| Applicant | Zimmer Biomet |
| Specialty / panel | Orthopedic |
| Product code | LPH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-01 |
| Decision date | 2026-09-23 |
| Review time (days) | 145 |
| Third-party review | No |
| Applicant location | Warsaw, IN, US |
| amount percentile | 54th of 414 (median 138, 1.1x median) |
| Peer records CSV (13 IN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-09-23
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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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: G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet and 13 Indiana peers
- Indiana FDAPulse records like this one: 13
- G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet's amount: 54th 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)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 145-day review: this device is a strong predicate for similar products.
- Posted 42 days ago.
What is the FDAPulse record for G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet in Indiana?
G7® Acetabular System (K261453) by Zimmer Biomet was cleared on 2026-09-23 after 145 days of review.
How does G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet compare to other Indiana FDAPulse records?
Its amount of 145 sits in the upper half (54th percentile) of 414 records; the median is 138. It is 42 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
G7® Acetabular System (K261453) vs. top 2 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| G7® Acetabular System (K261453) | IN | 2026-09-23 | This record |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 | View record → |
| Pediatric Nailing Platform Femur (K261345) | IN | 2026-09-24 | Compare G7® Acetabular System (K261453) vs Pediatric Nailing Platform Femur (K261345) → |
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