# K984331: Odi Ultimate Compression Hip Screw

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Designs, Inc.
- Decided: Jan 20, 1999 after 48 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: 2 generations back to K850886 (1985). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781762: Compression Hip Screw System, Howmedica Corp. (1978) Summary page 3.
- K823548: Compression Hip Screw Side-Plate, Howmedica Corp. (1982) Summary page 3.
- K900584: Alta Lag Screw and Compression Screw, Howmedica Corp. (1990) Summary page 3.
- K850886: Compression Hip Screw System, Pfizer, Inc. (1985) Summary page 3.
- K872223: Modified Omega Compression Hip Screw System, Howmedica Corp. (1987) Summary page 3.
- K955306: Omega+ Compression Screw System, Howmedica Corp. (1996). Our OCR of the scanned summary read K855306, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Howmedica Omega+ Compression Hip Screw System”.
- K922285: Agc and Maxim Knee Components with NTS, Biomet, Inc. (1992) Summary page 3.
- K791619: Dynamic Hip Screw, Synthes (Usa) (1979) Summary page 3.
- K861178: Depuy Compression Hip Screw System, Depuy, Inc. (1986) Summary page 4.
- K946156: Depuy Compression Hip Screw System, Depuy, Inc. (1995) Summary page 4.
- (no number) Ace Cannulated Hip Screw and Captured Hip Screw System: named in the summary without a submission number
- (no number) Richards KeyLock System: named in the summary without a submission number
- (no number) Richards Kwik-Key: named in the summary without a submission number
- (no number) Richards Ambi Compression Hip Screw: named in the summary without a submission number
- (no number) Richards Classic: named in the summary without a submission number
- (no number) Zimmer Compression Hip Screw with ECT: named in the summary without a submission number
- (no number) Zimmer Free-Lock: named in the summary without a submission number
- (no number) Zimmer Versa-Fx: named in the summary without a submission number
- (no number) Orthopedic Equipment Company’s (OECO.C.) Compression Hip Screw Plate: named in the summary without a submission number
- (no number) Wright Hip Compression Screw/Plate: named in the summary without a submission number
- (no number) Wright Concise Compression Hip Screw System: named in the summary without a submission number
- (no number) Wright Cannulated Plus Screw System: named in the summary without a submission number

## Most influential descendants
- K033286: Odi Talon Long Proximal Femoral Nail System (2004), 2 descendants of its own
- K111352: Talon Distalfix Proximal Femoral Nail (2011), 1 descendant of its own
- K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (2023), 0 descendants of its own

## Indications for use
The ODi Ultimate Compression Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.

Source page: https://510kreport.com/device/K984331
Methodology: https://510kreport.com/methodology