# K960537: K2 Bone Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Kinetikos Medical, Inc.
- Decided: Mar 25, 1996 after 47 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: 1 generation back to K792022 (1979). 7 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903810: Ace Cannulated Self Tapping Cancellous Bone Screw, Ace Medical Co. (1990) Summary page 3.
- K921622: Alphatec Compression Hip Screw System, Alphatec Mfg., Inc. (1992) Summary page 3.
- K931524: Fully Threaded Alta Cancellous Bone Screw, Howmedica Corp. (1994) Summary page 3.
- K940207: Titanium Alloy Bone Screws, Aesculap, Inc. (1994) Summary page 3.
- K924018: M3 Lag Screw Fixation System, Osteomed Corp. (1993) Summary page 3.
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 3.
- K792291: Synthes Reconstructive Plates 'Y' Plates, Synthes (Usa) (1979) Summary page 3.
- (no number) Johnson & Johnson: named in the summary without a submission number
- (no number) ISI Manufacturing: named in the summary without a submission number

## Most influential descendants
- K120493: Mini Cannulated Headed and Headless Screw Set (2012), 39 descendants of its own
- K123890: Acumed Cannulated Screw System (2013), 36 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own

## Indications for use
The indications for use of the K2 Bone Screw System™ are fixation/stabilization of small bone hand or small bone forefoot fractures.

Source page: https://510kreport.com/device/K960537
Methodology: https://510kreport.com/methodology