# K792022: Herbert Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 26, 1979 after 17 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
988 later devices descend from it; 18 cite it directly.
1 of 989 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962236: Scarf Thread-Head Screw (1996), 548 descendants of its own
- K062352: FRS Screw (2006), 527 descendants of its own
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K974876: Bionx Distal Radius Screw (1998), 419 descendants of its own
- K992947: Cannulated Smartscrew Models 224540C, 224570C (1999), 413 descendants of its own

## Recalls of this device
- Oct 11, 2013 · Class II · Z-1038-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Oct 11, 2013 · Class II · Z-1002-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Jun 26, 2006 · Not classified · Z-1349-06: Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
- Jun 26, 2006 · Not classified · Z-1350-06: Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
- Jun 26, 2006 · Not classified · Z-1348-06: Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
- Jun 26, 2006 · Not classified · Z-1351-06: Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

Source page: https://510kreport.com/device/K792022
Methodology: https://510kreport.com/methodology