# K252664: GMReis Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Nov 4, 2025 after 74 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K961555 (1996). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150648: Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm, Arthrex, Inc. (2015) Summary page 5.
- K251145: Arthrex PushLock Suture Anchors, Arthrex, Inc. (2025) Summary page 5.
- K183395: Arthrex 2.5 mm Tenodesis Screw, Arthrex, Inc. (2019) Summary page 5.
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 5.
- K051726: Arthrex Tenodesis Family, Arthrex, Inc. (2005) Summary page 5.

## Most influential descendants
- K254188: Meniscus Versaflex (2026), 0 descendants of its own

## Indications for use
The GMReis Suture Anchors is intended to be used for soft tissue reattachment in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, tendon transfers, Mid-foot reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hip: Capsular repair, acetabular labral repair.

Source page: https://510kreport.com/device/K252664
Methodology: https://510kreport.com/methodology