(81 days)
The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:
- Open and Closed Fractures
- Post-traumatic joint contracture which has resulted in loss of range of motion
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Pseudoarthrosis or non-union of long bones
- Limb lengthening by epiphyseal or metaphyseal distraction
- Correction of bony or soft tissue deformity
- Correction of segmental bony or soft tissue defects
- Joint arthrodesis
- Management of comminuted intra-articular fractures of the distal radius
The Stryker Hoffmann LRF System is indicated in adults for:
- Osteotomy
- Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
- Fusions and replantations of the foot
- Charcot foot reconstruction
- Lisfranc dislocations
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the modified telescopic strut and wire bolt components of the Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in K113327. The Hoffmann LRF System is an external fixation device that consists of Carbon and Aluminum Full/Open rings and ring segments, Aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.
The Hoffmann LRF (Limb Reconstruction Frame) System, specifically the modified telescopic strut and wire bolt components, demonstrated substantial equivalence to predicate devices through non-clinical laboratory testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Component | Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Telescopic Strut | Dynamic Component Testing | Not explicitly detailed, but implied to meet performance comparable to the predicate device per ASTM F1541-02. | Met performance comparable to the predicate device. |
| Telescopic Strut | Static Component Testing | Not explicitly detailed, but implied to meet performance comparable to the predicate device per ASTM F1541-02. | Met performance comparable to the predicate device. |
| Telescopic Strut | Dynamic Construct Testing | Not explicitly detailed, but implied to meet performance comparable to the predicate device when integrated into a construct, per ASTM F1541-02. | Met performance comparable to the predicate device. |
| Telescopic Strut | Static Construct Testing | Not explicitly detailed, but implied to meet performance comparable to the predicate device when integrated into a construct, per ASTM F1541-02. | Met performance comparable to the predicate device. |
| Wire Bolt | Dynamic Construct Testing | Not explicitly detailed, but implied to meet performance comparable to the predicate device when integrated into a construct, per ASTM F1541-02. | Met performance comparable to the predicate device. |
| Wire Bolt | Pull Out Testing | Not explicitly detailed, but implied to demonstrate sufficient pull-out strength comparable to the predicate device, per ASTM F1541-02. | Met performance comparable to the predicate device. |
| Overall System | Substantial Equivalence to Predicate | The acceptance criterion was that the modified components, when tested, would demonstrate "substantial equivalence" in performance characteristics to the predicate device (Hoffmann LRF System - K113327) according to ASTM F1541-02. This means the new components should perform at least as well as, and not introduce new or different questions of safety or effectiveness compared to, the previously cleared device. | Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System modified components are substantially equivalent to the predicate device components previously cleared in K113327 (Hoffmann LRF System) and Ilizarov External Fixation System (K031181-Smith and Nephew). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the modified telescopic strut and wire bolt components," implying a sufficient number of components were tested to satisfy the requirements of ASTM F1541-02. The specific quantity of individual components tested is not provided.
- Data Provenance: The testing was "non-clinical laboratory testing," indicating it was conducted in a controlled lab environment. The country of origin for the testing is not specified, but the sponsor, Stryker Trauma AG, is located in Switzerland. The documentation for the 510(k) submission was prepared in the U.S.
- Retrospective or Prospective: Prospective, as the tests were conducted specifically for this submission to evaluate the modified components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This was non-clinical laboratory testing of device components, not a clinical study involving human patients or expert interpretation of medical images/data to establish ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. This was non-clinical, objective laboratory testing against established engineering standards (ASTM F1541-02), not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical Testing: Clinical testing was not required for this submission."
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical external fixation system, not a software algorithm or AI system. The "standalone" performance refers to the device components' mechanical properties. The non-clinical laboratory testing effectively serves as the standalone performance evaluation of the modified components.
7. The Type of Ground Truth Used:
- The "ground truth" for the non-clinical testing was defined by the performance requirements and testing methodologies outlined in ASTM F1541-02 -- "Standard Specification and Test Methods for External Skeletal Fixation Device." The standard dictates how specific mechanical properties (e.g., dynamic and static strength, pull-out strength) should be measured and provides a framework for evaluating whether a device meets acceptable performance levels for its intended use. In this case, the ground truth was the objective mechanical properties as measured against the standard and compared to the predicate device.
8. The Sample Size for the Training Set:
- Not applicable. This was non-clinical mechanical testing, not a machine learning or AI study that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there was no training set.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.