# K090522: Osteomed Hand Plate and Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Jul 2, 2009 after 126 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 K954385 (1996). 12 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911936: Osteomed SBF System (SBF), Osteomed Corp. (1991) Summary page 1.
- K924138: Osteomed M3 System (SBF System), Osteomed Corp. (1993) Summary page 1.
- K030448: Osteomed 2.0 Locking Plates and Screws, Osteomed LP (2003) Summary page 1.
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 1.
- K050462: Sbi Hand Fixation System (TM), Small Bone Innovations, LLC (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K060349: Proguide Needle Set, Nucletron Corporation (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K061497: Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/ML, Excelsior Medical Corp. (2007). Our reading of the summary gave K061497, FDA’s number for Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/ML (Excelsior Medical Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stryker Small Bone Plating System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K132769: Acumed Hand Plating System (2014), 7 descendants of its own
- K141383: Acumed Hand Fracture System (2014), 6 descendants of its own
- K161894: SurgTech Trauma System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K120015: Osteomed Wrist Plating System (2012), 2 descendants of its own

## Indications for use
OsteoMed Hand Plating System is intended for use in trauma, general surgery and reconstructive procedures of the hand, wrist, or other bones appropriate for the size of the device. The OsteoMed Hand Plating System implants are intended for single use only.

Source page: https://510kreport.com/device/K090522
Methodology: https://510kreport.com/methodology