# K083151: Extremity Medical Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Jan 22, 2009 after 90 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: 3 generations back to K971723 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972326: Peba Anchor/Suture Combination, Orthopaedic Biosystems, Ltd. (1998) Summary page 1.
- K073509: Twinfix PK FP Suture Anchor, Smith & Nephew, Inc. (2008) Summary page 1.

## Most influential descendants
- K150166: Extremity Medical Suture Anchor (2015), 0 descendants of its own

## Indications for use
The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Source page: https://510kreport.com/device/K083151
Methodology: https://510kreport.com/methodology