SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES— 510(k) K033158

Clearance details

Applicant

Synthes (Usa)

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2003-09-30

Decision date

2003-11-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Paoli, PA, US

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• K253202 — Hoffmann LRF System2025-12-19

• K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM2015-03-30
• K131984 — SYNTHES SYNSONIC ULNA NAIL2014-03-31
• K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE2012-07-06
• K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM2012-06-18
• K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)2012-05-08

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

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033158.