# K972219: Orthopedic Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Nov 20, 1997 after 161 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: 1 generation back to K770128 (1977). 18 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770128: B.G. Compression System, Howmedica Corp. (1977) Summary page 1.
- K782123: Multiplicity of Products, Depuy, Inc. (1979) Summary page 1.
- K792291: Synthes Reconstructive Plates 'Y' Plates, Synthes (Usa) (1979) Summary page 1.
- K864924: Kirschner (R) Small Fragment Fixation System, Kirschner Medical Corp. (1987) Summary page 1.
- K890641: Acufex Cannulated Screws, Washers, Bone Plates, Acufex Microsurgical, Inc. (1989) Summary page 1.
- K903252: Broad Self-Compressing Plate, Onyx Medical Corp. (1990) Summary page 1.
- K912936: May Humerus Plates, Turnkey Intergration USA, Inc. (1991) Summary page 1.
- K914803: Schwabe Radius Plates, Link America, Inc. (1992) Summary page 1.
- K921338: Anspach Mini-Plating System, The Anspach Effort, Inc. (1993) Summary page 1.
- K922167: Alphatec Compression and Reconstruction Plates, Alphatec Mfg., Inc. (1992) Summary page 1.
- K923861: Luhr Pan Fixation System, Howmedica Corp. (1993) Summary page 1.
- K924085: Reconstruction Plate System, Sofamor Danek Mfg., Inc. (1992) Summary page 1.
- K930480: Variable Angular Hold Bone Plate System, Smith & Nephew Richards, Inc. (1994) Summary page 1.
- K930592: Ace Universal Reconstruction Plate, Ace Medical Co. (1993) Summary page 2.
- K930966: Baumer Plates, Baumer Ortopedia, Ltd. (1994) Summary page 2.
- K931687: Multiple Fragment Plate, Onyx Medical Corp. (1994) Summary page 2.
- K933112: Alphatec Compression and Reconstruction Plates, Alphatec Mfg., Inc. (1994) Summary page 2.
- K953644: Volar Distal Radius Plate, Synthes (Usa) (1996) Summary page 2.

## Cited in the summary but kept off the family tree
- K862224: The Woog and the Woog D. Powered Toothbrushes, Xouth, Inc. (1986). Our OCR of the scanned summary read K862224, FDA’s number for The Woog and the Woog D. Powered Toothbrushes (Xouth, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Warsaw Orthopedic Company, Warsaw Orthopedic Bone Plate”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K022139: Hip Tool Implant (2002), 7 descendants of its own
- 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

## Indications for use
The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

Source page: https://510kreport.com/device/K972219
Methodology: https://510kreport.com/methodology