# K992405: Axya Medical Inc, Bone Anchor System and Kit- (Bak)

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: Sep 22, 1999 after 64 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- 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 K932591 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980988: Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls), Axya Medical, Inc. (1998) Summary page 1.
- K983108: Suture Welding System and Kit (SWK), Axya Medical, Inc. (1998) Summary page 1.
- K932591: Endo-Judge, Synergistic Medical Technologies, Inc. (1993). Our OCR of the scanned summary read K832591, FDA’s number for Diacrom *PLG (Wellcome Diagnostics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Endo-Judge disposable suture placement system”.

## Most influential descendants
- K994313: Modification to Bone Anchor and Kit (Bak) (2000), 0 descendants of its own

## Indications for use
The Bone Anchor System and Kit is indicated for securing soft tissue structures to bone anchors in surgical procedures where bone anchors are indicated. Examples of these procedures include: Shoulder procedures (e.g. Rotator cuff repair) Knee procedures (e.g. Patellar ligament / tendon avulsion repair) Ankle procedures (e.g. Achilles tendon reconstruction and repair) Foot procedures (e.g. Hallux valgus reconstruction) Elbow procedures (e.g. Biceps tendon reattachment) Bladder neck suspension (female urinary incontinence due to urethral hypermobility) The BAK is indicated for use in both traditional open surgery and endoscopic surgical procedures.

Source page: https://510kreport.com/device/K992405
Methodology: https://510kreport.com/methodology