# K072411: Aap Bone Plates and Screw Implants

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Mar 20, 2008 after 206 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 K974908 (1998). 4 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983495: Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420, Syntec Scientific Corp. (1998) Summary page 4.
- K974908: Synthes Sterile 2.7 MM Reconstruction Plates, Synthes (Usa) (1998) Summary page 4.
- K000636: Stryker Trauma Plating System, Howmedica Osteonics Corp. (2000)
- K012162: Stryker Plating System Basic Fragment Set, Howmedica Osteonics Corp. (2001) Summary page 4.
- (no number) Synthes Bone Plates and Bone Screws for standard Osteosynthesis (Preamendment): named in the summary without a submission number

## Most influential descendants
- K120360: Ortho Solutions Trauma Plates for Osteosysnthesis (2012), 2 descendants of its own
- K223772: PRO Plating System, Stryker Trauma Pelvic Set (Matta) (2023), 1 descendant of its own
- K202764: Ortho Solutions Plating System (2020), 1 descendant of its own
- K260054: I.T.S. PRS Phoenix II (2026), 0 descendants of its own
- K210658: Volition Plating System (2021), 0 descendants of its own

## Indications for use
The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management). All oop bone plates and screws are for single use only and are not intended for any spinal fixation procedures.

Source page: https://510kreport.com/device/K072411
Methodology: https://510kreport.com/methodology