# K022139: Hip Tool Implant

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Sciences, Inc.
- Decided: Sep 23, 2002 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
Longest line of descent: 3 generations back to K850886 (1985). 41 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982222: Synthes (Usa) Distal Femur Plate (DFP) System, Synthes (Usa) (1998) Summary page 2.
- K000066: Synthes (Usa) Locking Condylar Plate (LCP) System, Synthes (Usa) (2000) Summary page 2.
- K011459: Wujin #3 Femoral Bone Plate, Biopro, Inc. (2001)
- K970503: Depuy Ace Trochanteric Side Plate, Depuy Ace Medical Co. (1997) Summary page 2.
- K012162: Stryker Plating System Basic Fragment Set, Howmedica Osteonics Corp. (2001)
- K963700: Metagen High Tibial Osteotomy System, Metagen, LLC (1997) Summary page 2.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 3.
- K983988: Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate, Syntec Scientific Corp. (1999) Summary page 3.
- K972219: Orthopedic Plate System, Ferguson Medical (1997) Summary page 3.
- K982553: Osteo Compression Hip Screw System, Osteonics Corp. (1998) Summary page 3.
- K970258: Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck Fractures, Ferguson Medical (1997) Summary page 3.
- K994158: Macrosorbos Protective Sheet, Macropore Biosurgery, Inc. (2000). Our reading of the summary gave K994155, FDA’s number for Excelsior 1018 Microcatheter (Boston Scientific, Target). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MacroPoreOS Protective Sheet”.
- K003788: Synthes Resorable Meshes and Sheets, Synthes (Usa) (2001) Summary page 3.
- K011139: Lorenz Lactosorb Panels and Fasteners, Biomet, Inc. (2001)
- K984390: Lactosorb Panels and Fasteners, Biomet, Inc. (2000) Summary page 3.

## Most influential descendants
- K063709: TS-Bone Hip Tool (2007), 1 descendant of its own
- K040850: Tsy Shoulder Plate Implant (2004), 1 descendant of its own
- K072175: Titanium Hip Tool Locking Plate (2007), 0 descendants of its own
- K063033: Modification to Titanium Shoulder Plate Implant (2006), 0 descendants of its own
- K052538: S-Bone Hip Tool (2005), 0 descendants of its own

## Indications for use
The Hip Tool™ Implant is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

Source page: https://510kreport.com/device/K022139
Methodology: https://510kreport.com/methodology