# K983186: Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Oct 21, 1998 after 40 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: 2 generations back to K926384 (1993). 6 ancestors in all.
80 later devices descend from it; 3 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964805: Bio-Anchor, Linvatec Corp. (1997) Summary page 4.
- K963369: Bio-Anchor, Linvatec Corp. (1997) Summary page 4.
- K953954: Preloaded Soft Tissue Anchor, Linvatec Corp. (1996) Summary page 4.

## Most influential descendants
- 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
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own

## Indications for use
The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder Bankart lesion repairs SLAP lesion repairs Acromio-clavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Altoid 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. Extracapsular 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 Extracapsular reconstruction, Iliotibial band tenodesis Patellar realignment and tendon repairs Bladder Neck Suspension 1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Source page: https://510kreport.com/device/K983186
Methodology: https://510kreport.com/methodology