# K083150: G-Force Tenodesis Screw

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 15, 2009 after 83 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K151701: Tenodesis screw system (2016), 0 descendants of its own

## Indications for use
Indications for the G-FORCE Tenodesis Screw include use in soft tissue reattachment procedures in the shoulder, foot/ankle, knee, elbow and wrist/hand where the sizes offered are patient appropriate. Specific indications include the following: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsule Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux VaIgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction and tendon transfers in the foot and ankle. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Wrist/Hand: Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty, Carpal Ligament Repair/Reconstruction and tendon transfers in the wrist and hand.

Source page: https://510kreport.com/device/K083150
Methodology: https://510kreport.com/methodology