# K033639: Acumed Lower Extremity Congruent Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jan 15, 2004 after 56 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000684 (2000). 14 ancestors in all.
98 later devices descend from it; 6 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000)
- K974537: Synthes Cannulated Angle Blade Plate (Cabp) System, Synthes (Usa) (1998) Summary page 1.
- K982347: Depuy Ace Timax Pilon Plate, Depuy Ace Medical Co. (1998) Summary page 1.
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 1.
- K981775: Depuy Ace Timax Calcaneal Peri-Articular Plate, Depuy Ace Medical Co. (1998) Summary page 1.

## Most influential descendants
- K073375: Newdeal Tibiaxys System (2008), 73 descendants of its own
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates (2011), 69 descendants of its own
- K100176: Ascension Ankle Fusion Plate System (2010), 56 descendants of its own
- K121425: Ortholoc 3DI Ankle Fusion Plating System (2012), 53 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own

## Recalls of this device
- Feb 14, 2008 · Not classified · Z-2111-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2114-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2115-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2108-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2113-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2117-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2116-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2112-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2110-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2109-2008: Product sterility may be compromised.

## Indications for use
The Acumed Lower Extremity Congruent Plate System provides fixation during fractures, fusions, and osteotomies for the phalanges, metatarsals, tarsals, tibia and fibula.

Source page: https://510kreport.com/device/K033639
Methodology: https://510kreport.com/methodology