# K964805: Bio-Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jun 9, 1997 after 192 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953954 (1996). 1 ancestor in all.
81 later devices descend from it; 3 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953954: Preloaded Soft Tissue Anchor, Linvatec Corp. (1996) Summary page 3.
- (no number) Bio-Anchor: named in the summary without a submission number

## Most influential descendants
- K983186: Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor (1998), 80 descendants of its own
- K020056: Duet Suture Anchor (2002), 78 descendants of its own
- K030388: Impact Suture Anchor. Model 433510 (2003), 77 descendants of its own
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), 76 descendants of its own
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own

## Indications for use
The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction. Shoulder 1. Bankart lesion repairs 2. SLAP lesion repairs 3. Acromio-clavicular separation repairs 4. Rotator cuff tear repairs 5. Capsular shift or capsulolabral reconstructions 6. Biceps tenodesis 7. Deltoid repairs Foot and Ankle 1. Hallux Valgus repairs 2. Medial or lateral instability repairs/reconstructions 3. Achilles tendon repairs/reconstructions 4. Midfoot reconstructions Elbow, Wrist and Hand 1. Scapholunate ligament reconstructions 2. Ulnar or radial collateral ligament reconstructions 3. Tennis elbow repair 4. Biceps tendon reattachment Knee 1. Extra-capsular repairs and reattachments of: a. medial collateral ligament b. lateral collateral ligament c. posterior oblique ligament or joint capsule to tibia d. joint capsule closure to anterior proximal tibia 2. Extracapsular reconstruction, iliotibial band tenodesis 3. Patellar realignment and tendon repairs

Source page: https://510kreport.com/device/K964805
Methodology: https://510kreport.com/methodology