Hoffmann LRF (Limb Reconstruction Frame) System— 510(k) K153377
Substantially EquivalentStryker GmbH
FDA 510(k) clearance K153377 for Hoffmann LRF (Limb Reconstruction Frame) System, Substantially Equivalent on 2016-04-11. Applicant: Stryker GmbH. Device class: 2.
Clearance details
- Applicant
- Stryker GmbH
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code KTT
view allMore clearances from Stryker GmbH
view all- K261481 — Pangea Femur Reconstruction System
- K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
- K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
- K250163 — T2 Alpha Femur Retrograde Nailing System
- K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K153377
K-number listed on FDA's recall record- Z-1191-2023 — stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
- Z-2160-2017 — Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153377.
Data sourced from openFDA. This site is unofficial and independent of the FDA.