Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc
K150209 is the FDA 510(k) clearance record for Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc, a class II device, cleared for Depuy Mitek, A Johnson and Johnson Company on under FDA product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). FDA records list 80 510(k) clearances for DePuy Mitek, Inc., from to . As of , FDA records show 5 recalls naming K150209.
Clearance record
- Decision date
- Received
- (249 days to decision)
- Product code
- MAI Fastener, Fixation, Biodegradable, Soft Tissue
- Regulation
- 21 CFR 888.3030
- Device class
- Class II
- Review panel
- Orthopedic
- Applicant
- Depuy Mitek, A Johnson and Johnson Company 325 Paramount Dr., Raynham MA
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code MAI
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 2 |
| March 2026 | 1 |
| April 2026 | 0 |
| May 2026 | 1 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 1 |
| September 2026 | 0 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
