# K973810: DRG Large Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Dolphin Medical Technologies, Inc.
- Decided: Jan 5, 1998 after 90 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.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
The Dolphin Medical Technologics DRG Large Screw™ System will be used on indications that are common with presently marketed devices. The indications for use of the DRG Large Screw™ System reconstruction of intra-articular epiphyseal and of metaphyseal fractures. Specifically, intracapsular fractures of the hip, slipped capital femoral epiphyses, tibial plateau fractures, distal femoral condyle fractures; ankle, elbow and shoulder fractures where indicated.

Source page: https://510kreport.com/device/K973810
Methodology: https://510kreport.com/methodology