SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM— 510(k) K122455

Clearance details

Applicant

Synthes

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2012-08-13

Decision date

2013-04-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Chester, PA, US

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• K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
• K253291 — Excelsior System2026-01-20
• K253202 — Hoffmann LRF System2025-12-19

• K123723 — SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM2013-09-05
• K113071 — SYNTHECEL DURA REPLACEMENT DEVICES2012-01-09
• K110604 — VBB SYSTEM2011-12-13
• K093772 — SYNTHES STERNAL FIXATION SYSTEM2010-03-29
• K013072 — CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)2002-11-26

Death

11

Injury

3,097

Malfunction

1,261

Total

4,369

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2451-2015 — Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult fractures; )L) for use to provide treatment for long bone and pelvic fractures that require external fixation; and (DO) for fracture fixation (open and closed),pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphysical distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.Class II·Terminated·Synthes (USA) Products LLC·20150729
• Z-1833-2014 — Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.Class II·Terminated·Synthes, Inc.·20140410

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122455.