# K990770: Biorc Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jul 30, 1999 after 143 days
- Product code: HWC (Screw, Fixation, Bone)
- 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 K926384 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963932: Preloaded Soft Tissue Anchor, Linvatec Corp. (1997) Summary page 4.
- K911837: Suretac Polyglyconate Absorbable Fixation Device, Acufex Microsurgical, Inc. (1991) Summary page 4.
- K983186: Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor, Linvatec Corp. (1998) Summary page 4.

## Indications for use
The BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs Foot and Ankle 1. Hallux Valgus repairs 2. Medial or lateral instability repairs/reconstructions 3. Achilles tendon repalrs/reconstructlons 4. Midfoot reconstructions Elbow, Wrist and Hand 1. Scapholunate ligament reconstructions 2. Ulnar or radial collateral ligament reconstructions 3. Lateral and Medial Epicondylitis 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 2. Extracapsular reconstruction, iliotibial band tenodesis 3. Patellar realignment and tendon repalr(%;) 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/K990770
Methodology: https://510kreport.com/methodology