# K012655: Congruent Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Nov 7, 2001 after 86 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000684 (2000). 7 ancestors in all.
792 later devices descend from it; 28 cite it directly.
1 of 800 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890939: Dupont Distal Humeral Nail, Howmedica Corp. (1989) Summary page 1.
- K951415: Luhr Pan Fixation System Condensed Straight Plate, Y Plates and 1.5MM Bone Screw, Howmedica Corp. (1995) Summary page 1.
- K011334: Synthes Curved Reconstruction Plate, Synthes (Usa) (2001) Summary page 1.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000) Summary page 1.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 1.
- K912936: May Humerus Plates, Turnkey Intergration USA, Inc. (1991) 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
- 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
- K021626: Hallu Plates (2002), 280 descendants of its own
- K040907: Arthrex Small Fragment Plates and Screws (2004), 249 descendants of its own

## Recalls of this device
- Apr 14, 2010 · Not classified · Z-1807-2010: The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-uni
- Feb 14, 2008 · Not classified · Z-2129-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2132-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2128-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2126-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2123-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2124-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2120-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2130-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2121-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2125-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2122-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2131-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2127-2008: Product sterility may be compromised.
- Jul 9, 2007 · Not classified · Z-2135-2008: Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.
- Jun 29, 2007 · Not classified · Z-2153-2008: Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.

## Indications for use
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.

Source page: https://510kreport.com/device/K012655
Methodology: https://510kreport.com/methodology