# K043410: Epiphysis Screw

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
- Decided: Feb 24, 2005 after 76 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K862157 (1986). 4 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 1.
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 1.
- K862157: Omc Orthomet Cannulated Screw, Orthomet, Inc. (1986) Summary page 1.
- K903810: Ace Cannulated Self Tapping Cancellous Bone Screw, Ace Medical Co. (1990) Summary page 1.
- (no number) Zimmer MAGNA-Fx Cannulated Screw Fixation System: named in the summary without a submission number
- (no number) Richards/Smith Nephew Universal Cannulated Screw: named in the summary without a submission number
- (no number) DePuyAce ACE SCFE Screw: named in the summary without a submission number

## Most influential descendants
- K082949: Orthopediatrics Bone Screws (2008), 11 descendants of its own
- K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System (2011), 7 descendants of its own
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K110959: Orthopediatrics Blade Plate System (2011), 2 descendants of its own
- K162307: OrthoPediatrics Locking Proximal Femur System Cortical Screws (2016), 1 descendant of its own

## Indications for use
The I.T.S. Epiphysis Screw is a titanium implant fracture fixation screw system for a slipped femoral capital epiphysis and alternative cancellous bone screw fixation where accurate screw placement is required such as in the pelvis, ankle, knee, etc.. Indications for Use include fracture fixation of large bone fragments, such as femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses. The system is not intended for spinal use.

Source page: https://510kreport.com/device/K043410
Methodology: https://510kreport.com/methodology