HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM— 510(k) K113327

Clearance details

Applicant

Stryker Corp.

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2011-11-10

Decision date

2012-03-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwah, NJ, US

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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-1526-2018 — Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.Class II·Terminated·Stryker GmbH·20180312
• Z-0695-2013 — Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.Class II·Terminated·Stryker Howmedica Osteonics Corp.·20121025
• Z-0266-2013 — Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.Class II·Terminated·Stryker Howmedica Osteonics Corp.·20120703

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113327.