# Smith & Nephew Inc. (specification developer, Andover, MA): 2 new FDA device listings, incl. fastener, fixation, nondegradable, soft tissue

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Smith & Nephew Inc. |
| Owner / operator | Smith & Nephew, Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Andover, MA, US |
| New listings | 2 |
| Devices | Fastener, Fixation, Nondegradable, Soft Tissue; Intra-Articular Orthopedic Stereotaxic Navigation Instrument |
| Product codes | MBI, SIQ |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | 2.8mm QFIX Knotless All Suture Anchor; 72205785 License for Imaging Center Only; 72205790 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON Adjustable Fixation Device; 72205911 TESSA Control Unit Country Kit, En, US; 72205811 TESSA Control Unit Country Kit, EN, UK; 72205810 TESSA Control Unit Accessory Box; 72205791 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON QUAD Adjustable Fixation Device; 72205803 TESSA ACL Femur Curved Aimer Kit with ENDOBUTTON CL Ultra, 15mm |
| First new listing | 2026-07-22 |
| Latest new listing | 2026-07-30 |
| FDA registration number | 3003604053 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.