# K990019: DRG Medium Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Dolphin Medical Technologies, Inc.
- Decided: Mar 15, 1999 after 70 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.
- 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.
- K940207: Titanium Alloy Bone Screws, Aesculap, Inc. (1994) Summary page 3.
- K931524: Fully Threaded Alta Cancellous Bone Screw, Howmedica Corp. (1994) Summary page 3.
- K921622: Alphatec Compression Hip Screw System, Alphatec Mfg., Inc. (1992) Summary page 3.

## Indications for use
The Dolphin Medical Technologies DRG Medium Screw™ System will be used on indications that are common with presently marketed devices. Specifically, malleolar, radius, ulna, olecranon, displaced fibula and humerus bone fractures. Aditionally, fixation/stabilization of the humeral shaft, distal and proximal humerus, distal and proximal radius and ulna, radial and ulna shaft, distal tibia and ankle, talus-calcaneus-metatarsal, fibular shaft malleolus fractures where indicated; The DRG Medium Screw™ System is indicated for: Humeral Shaft Distal and proximal humerus Distal and proximal radius and ulna Radial and ulna shaft Distal tibia and ankle Talus-calcaneus-matatarsal Fibular shaft and Malleolus fractures Intermediate Bone Fractures

Source page: https://510kreport.com/device/K990019
Methodology: https://510kreport.com/methodology