# K141011: G-Force Gen 2 Suture Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 30, 2014 after 103 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: 2 generations back to K971282 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100579: G-Force TI Suture Anchor System, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Most influential descendants
- K170265: GRAVITYTM PEEK-OPTIMA Suture Anchor (2017), 0 descendants of its own

## Indications for use
The 0-FORCE® Gen 2 Suture Anchor System is indicated for use: - In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; * In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; * In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; * In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis; * In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments. medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments, Tendon Transfers, tendon reattachments, and ligament reconstructions of the midfoot, forefoot, and hindfoot procedures associated with flatfoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including: o Achilles reattachment/reconstruction o Flexor Digitorum Longus Transfer " Flexor Hallucis Longus Transfer o Extensor Hallucis Longus Transfer o Brostrom Procedures o Peroneal Tendon Relocation o Capsule Repair o Deltoid reconstruction / reattachment o Plantar Plate Repair o Spring Ligament Repair

Source page: https://510kreport.com/device/K141011
Methodology: https://510kreport.com/methodology