# K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 10, 2003 after 19 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981372 (1998). 8 ancestors in all.
690 later devices descend from it; 28 cite it directly.
1 of 699 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 1.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 1.
- K000066: Synthes (Usa) Locking Condylar Plate (LCP) System, Synthes (Usa) (2000) Summary page 1.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 1.

## Most influential descendants
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity (2005), 584 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
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K050457: Merete Metafix Small Fragment Bone Plate System (2005), 258 descendants of its own

## Recalls of this device
- Jul 20, 2010 · Not classified · Z-2314-2010: Inner packaging of sterile product was not sealed. Lack of sterility assurance.

## Indications for use
The Smith & Nephew Locking Bone Plate System is used for adult and 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 (particularly in osteopenic bone); treatment of the calcaneal; hip arthrodesis, and provisional hole fixation. Components in the Smith & Nephew Locking Bone Plate System are for single use only.

Source page: https://510kreport.com/device/K033669
Methodology: https://510kreport.com/methodology