# K971282: Anchorlok and Anchorlok RL Soft Tissue Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jun 27, 1997 after 81 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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 its predicate without a number.
- (no number) ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System: named in the summary without a submission number
- (no number) Mitek Anchor: named in the summary without a submission number

## Most influential descendants
- K100579: G-Force TI Suture Anchor System (2010), 2 descendants of its own
- K141011: G-Force Gen 2 Suture Anchor System (2014), 1 descendant of its own
- K100630: G-Force Peek Suture Anchor System (2010), 1 descendant of its own
- K170265: GRAVITYTM PEEK-OPTIMA Suture Anchor (2017), 0 descendants of its own
- K990095: Straight-in-Orthopedic Bone Screw Fixation System (1999), 0 descendants of its own

## Recalls of this device
- Sep 20, 2011 · Not classified · Z-0059-2012: The product is labeled with an expiration date without adequate justification.
- Sep 20, 2011 · Not classified · Z-0064-2012: The product is labeled with an expiration date without adequate justification.
- Sep 20, 2011 · Not classified · Z-0067-2012: The product is labeled with an expiration date without adequate justification.
- Sep 20, 2011 · Not classified · Z-0065-2012: The product is labeled with an expiration date without adequate justification.
- Sep 20, 2011 · Not classified · Z-0066-2012: The product is labeled with an expiration date without adequate justification.
- Sep 20, 2011 · Not classified · Z-0058-2012: The product is labeled with an expiration date without adequate justification.
- Sep 20, 2011 · Not classified · Z-0062-2012: The product is labeled with an expiration date without adequate justification.
- Sep 20, 2011 · Not classified · Z-0063-2012: The product is labeled with an expiration date without adequate justification.
- Sep 20, 2011 · Not classified · Z-0060-2012: The product is labeled with an expiration date without adequate justification.
- Sep 20, 2011 · Not classified · Z-0061-2012: The product is labeled with an expiration date without adequate justification.

## Indications for use
The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is intended 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; . Female urinary incontinence due to urethral hypermobility; . 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; . Lateral canthoplasty

Source page: https://510kreport.com/device/K971282
Methodology: https://510kreport.com/methodology