# K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 9, 1999 after 83 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
728 later devices descend from it; 36 cite it directly.
1 of 729 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Richards Bone Plates and Bone Screws (Smith & Nephew [f/k/a Richards Medical Company]): named in the summary without a submission number
- (no number) Osteo Bone Plates and Bone Screws (Smith & Nephew): named in the summary without a submission number
- (no number) Titanium Plates (Synthes): named in the summary without a submission number
- (no number) Basic Screw Set (Synthes): named in the summary without a submission number
- (no number) ECT Plates and Screws (Zimmer): named in the summary without a submission number
- (no number) TiMAX™ Large Fragment System (DePuy): named in the summary without a submission number
- (no number) TiMAX™ Bone Screws (DePuy): named in the summary without a submission number

## Most influential descendants
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) (2003), 690 descendants of its own
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity (2005), 584 descendants of its own
- K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws (2006), 531 descendants of its own
- K062216: Peri-Loc Periarticular Locked Plating System (2006), 501 descendants of its own
- K071563: Peri-Loc Periarticular Locked Plating System (2007), 495 descendants of its own

## Indications for use
The Smith & Nephew Bone Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.

Source page: https://510kreport.com/device/K993106
Methodology: https://510kreport.com/methodology