Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc.
Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc. (Massachusetts): 510(k) cleared for Anika Therapeutics, Inc. Its amount of 105 is below the median of 138 (38th percentile). Dated 48 days ago, it serves as a historical benchmark. Score 30/100. 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: 105 · 38th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261869 |
| Device | Integrity Retractable Implant Inserter (6000127) |
| Applicant | Anika Therapeutics, Inc. |
| Specialty / panel | Orthopedic |
| Product code | MBI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-04 |
| Decision date | 2026-09-17 |
| Review time (days) | 105 |
| Third-party review | No |
| Applicant location | Beford, MA, US |
| amount percentile | 38th of 414 (median 138, 0.8x 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
- Refunds on request within 14 days
Top FDAPulse records (MA first): GSPE Spacer (K260063) · Sensinel Cardiopulmonary Management (CPM) System (K260801) · multiFiltratePRO System (K261203) · a2z-Abdo-Triage (K260906) · BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125) · Browse all by state and category →
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: Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc. and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc.'s amount: 38th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 105-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc. in Massachusetts?
Integrity Retractable Implant Inserter (6000127) (K261869) by Anika Therapeutics, Inc. was cleared on 2026-09-17 after 105 days of review.
How does Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc. compare to other Massachusetts FDAPulse records?
Its amount of 105 is below the median (38th percentile); smaller records often move faster and face less competition. It is 48 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
Integrity Retractable Implant Inserter (6000127) (K261869) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Integrity Retractable Implant Inserter (6000127) (K261869) | MA | 2026-09-17 |
| GSPE Spacer (K260063) | MA | 2026-09-11 |
| Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Co | MA | 2026-10-23 |
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