Footprint Mini PK, 3.5mm Suture Anchor
FDA 510(k) clearance K233730 · decided 2024-01-17
Clearance details
- K-number
- K233730
- Device name
- Footprint Mini PK, 3.5mm Suture Anchor
- Applicant
- Smith & Nephew
- Decision
- Substantially Equivalent
- Date received
- 2023-11-21
- Decision date
- 2024-01-17
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smith & Nephew
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Grappler Suture Anchor System (K262047) | Paragon 28, Inc. | 2026-08-03 |
| AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down (K262369) | Stryker Endoscopy | 2026-07-30 |
| Suture Button Repair System (K261770) | Skeletal Dynamics, Inc. | 2026-07-29 |
| Thunderbolt System (K261632) | Responsive Arthroscopy, Inc. | 2026-07-20 |
| Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) (K261968) | Smith & Nephew, Inc. | 2026-07-09 |
| Arthrex FiberButton (K260018) | Arthrex, Inc. | 2026-06-26 |
| Dione PEEK Screw System (K253130) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| Y-Knotless™ Flex Anchors (K261363) | CONMED Corporation | 2026-05-13 |
| Anchor with Fiber Wire and Disposable Inserter (K253027) | Ortobio S.A. | 2026-05-06 |
| ArthroTAK Tendon Anchor Kit (K252635) | ArthroTAK, LLC | 2026-05-01 |
| Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (K260921) | Tigon Medical | 2026-04-21 |
| Arthrex FiberTak Suture Anchor (K260561) | Arthrex, Inc. | 2026-03-20 |
Recalls involving this device
No recalls on record reference this clearance.