# K170265: GRAVITYTM PEEK-OPTIMA Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 23, 2017 after 27 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 K971282 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141011: G-Force Gen 2 Suture Anchor System, Wrightmedicaltechnologyinc (2014) Summary page 5.
- K100579: G-Force TI Suture Anchor System, Wrightmedicaltechnologyinc (2010) Summary page 5.
- K100630: G-Force Peek Suture Anchor System, Wrightmedicaltechnologyinc (2010) Summary page 5.

## Indications for use
The GRAVITY PEEK-OPTIMA® 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 o 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/K170265
Methodology: https://510kreport.com/methodology