(70 days)
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 t
- 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 additional components as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in KI 13327. 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. The additional components will consist of the following: carbon foot ring, foot arch, hinge coupling and compatibility with the previously cleared Hoffmann 3 couplings. 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 provided text describes a 510(k) submission for a medical device (external fixation device) and explicitly states that clinical testing was not required. This means there is no study conducted to prove device performance against acceptance criteria in a clinical setting with human subjects.
The submission focuses on non-clinical laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. Therefore, the following information, which pertains to clinical studies, cannot be provided based on the given text:
- A table of acceptance criteria and the reported device performance (in a clinical context).
- Sample size used for the test set and data provenance (for clinical data).
- Number of experts used to establish ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used (for clinical data).
- Sample size for the training set (for clinical data).
- How ground truth for the training set was established (for clinical data).
However, the provided text does detail the non-clinical testing performed. Here's a summary of that information:
Acceptance Criteria and Device Performance (Non-Clinical Testing)
| Acceptance Criteria (Test) | Reported Device Performance (Conclusion) |
|---|---|
| Static Cantilever Bending Test - Carbon Foot Ring | Demonstrated substantial equivalence to predicate device components. |
| Static Compression Test - Foot Arch | Demonstrated substantial equivalence to predicate device components. |
| Static Cantilever Test - Hinge Coupling | Demonstrated substantial equivalence to predicate device components. |
| Dynamic Test - Frame Construct | Demonstrated substantial equivalence to predicate device components. |
| Compatibility Engineering Evaluation | Demonstrated substantial equivalence to predicate device components. |
Study Details (Non-Clinical Testing):
- Sample size used for the test set and data provenance: Not explicitly stated beyond "additional components and component compatibility." The provenance is internal laboratory testing by Stryker Trauma AG.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was engineering performance testing.
- Adjudication method: Not applicable. This was engineering performance testing.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No, this was not a clinical study.
- Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a mechanical device, not an algorithm.
- Type of ground truth used: Based on the compliance with ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device," the ground truth is defined by the standardized test methods and their performance requirements.
- Sample size for the training set: Not applicable. This was engineering performance testing.
- How the ground truth for the training set was established: Not applicable. This was engineering performance testing.
Conclusion stated by the submitter: "Clinical testing was not required for this submission. The Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to the predicate devices identified in this premarket notification."
§ 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.