Hoffmann LRF System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Stryker GmbH
Identity
- Trade Name
- HOFFMANN EUDAMEDFDA UDI
- Generic Name
- External orthopaedic fixation system, reusable FDA UDI
- Device Name
- HOFFMANN II - FRAME COMPONENTS - RODS - CLASS I - NON STERILE EUDAMEDConnecting Rod Compact FDA UDI
- Model / Reference
- 5048-5-200 EUDAMEDFDA UDI08858251002883TQ EUDAMED
- Description
- Connecting Rod Compact FDA UDI
Identifiers
- Catalog Number
- 5048-5-200 FDA UDI
- Primary DI / UDI-DI
- 04546540492913 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251002883TQ EUDAMED
- 510(k) Number
- K253202 FDA 510(k)
- FDA Product Code
- KTT FDA 510(k)FDA UDI
- EMDN Code
- P09120499 EXTERNAL BONE FIXATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- External orthopaedic fixation system, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 200.0 Millimeter FDA UDI
The Hoffmann LRF System is a circular external fixation device designed for orthopedic stabilization. It employs a modular framework of rings and telescopic struts with multiplanar, ball-jointed fixation bolts to provide adjustable and stable skeletal alignment for both pediatric (ages 2–21) and adult patients.
This system is intended for use in orthopedic settings, featuring reusable components with semi-automatic controllers and mobile application support for enhanced precision. Supplied sterile or non-sterile as required, the device adheres to FDA 510(k) and MDR regulatory standards, with model-specific configurations available for tailored clinical applications.
Frequently asked questions
What age groups is the Hoffmann LRF System designed to support in clinical use?
The Hoffmann LRF System is specifically designed for both pediatric patients aged 2–21 years and adult patients. Its modular framework and adjustable components allow for tailored stabilization across these age ranges, ensuring adaptability to varying skeletal anatomies.
Is the Hoffmann LRF System reusable, or is it intended for single-use only?
The Hoffmann LRF System is designed with reusable components, including the modular rings, telescopic struts, and fixation bolts. This makes it cost-effective for repeated use in orthopedic settings, though sterile and non-sterile configurations are available based on clinical needs.
How does the system ensure precise skeletal alignment during orthopedic procedures?
The Hoffmann LRF System achieves precise alignment through its multiplanar, ball-jointed fixation bolts and semi-automatic controllers. These features allow for fine adjustments in multiple directions, while the optional mobile application support further enhances accuracy by enabling real-time adjustments and monitoring.
What regulatory pathways does the Hoffmann LRF System follow, and how does this affect its use?
The Hoffmann LRF System follows both FDA 510(k) and MDR (Medical Device Regulation) pathways, confirming its compliance with stringent safety and performance standards. This means it has undergone rigorous evaluation for orthopedic stabilization applications, ensuring reliability for clinicians in both pediatric and adult cases.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hoffmann LRF smartHEX | Stryker, Hoffmann LRF Circular External Fixation | Stryker, Hoffmann LRF System (K253202) — FDA 510 (k) | Innolitics, Ankle external fixation system - Hoffmann LRF Hexapod - Stryker ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253202 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker GmbH
Sources (3)
- FDA 510(k) K253202 24 fields · synced Sep 18, 2026
- FDA UDI 0a6faccb-c2d0-4923-a3ef-648d1baa31bd 35 fields · synced May 30, 2026
- EUDAMED 153ccae7-254b-4744-800d-4918a6b74e4b 61 fields · synced Sep 17, 2026