# Smith & Nephew Inc. (manufacturer, Mansfield, 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 | Manufacturer |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Mansfield, 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; 72205781 TESSA ACL Femur System License Software, No Cloud; 72205793 TESSA ACL Femur Straight Aimer Kit with ENDOBUTTON CL Ultra, 15mm; 72205778 TESSA ACL Femur Curved Aimer Kit; 72205801 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON QUAD Adjustable Fixation Device; 72205791 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON QUAD Adjustable Fixation Device; 72205777 TESSA ACL Femur Straight Aimer Kit; 72205782 TESSA Marker A |
| First new listing | 2026-07-22 |
| Latest new listing | 2026-07-30 |
| FDA registration number | 1219602 |
| 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: 2026-10-28T20:51:27.468Z.
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.