(355 days)
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
- Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
- Arthrodesis of the foot, wrist and elbow.
- Small and long bone osteotomies.
- Fracture fixation of small bones, small bone fragments and long bones.
Large Cannulated Screws (5mm and larger in diameter) are intended for use in: - Fixation of fractures in long bones and long bone fragments.
- Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
- Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in: - Slipped capital femoral epiphysis
- Pediatric femoral neck fractures
- Tibial plateau fractures
- SI joint disruptions
- Intercondylar femur fractures
- Subtalar arthrodesis
- Fixation of pelvis and iliosacral joint.
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
The WasherLoc™ and No-Profile Screw and Washer Systems are internal soft tissue fixation devices that aid in arthroscopic and orthopedic reconstructive procedures. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.
The No-Profile Screw and Washer System includes titanium alloy (Ti-6A1-4V) screws and washers in various lengths/sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 70mm are available. The No-Profile Washers are available in 14mm, 16mm, and 18mm diameters with and without spikes. The spikes on the washers are not intended for additional fixation as used with the No-Profile screws.
The WasherLoc™ Tibial Fixation System includes titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 60mm are available. The WasherLoc™ Washers are available in 14mm, 16mm, and 18mm diameters with spikes intended for additional fixation.
The Biomet Cannulated Screw System is designed for a variety of internal fixation, aiding in the alignment, stabilization, and healing of fractures or osteotomies to the skeletal system. The Biomet Cannulated Screw System has multiple variants included which fluctuate in screw diameters and lengths, and include the associated essential instruments that aid in fracture fixation.
The Biomet Cannulated Screw System consists of screw variants, which are available in diameters of 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm. Each screw diameter is accompanied by instruments that are designed specifically for a given diameter. Washers are also part of the Biomet Cannulated Screw System and are sized 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm to specifically match each screw diameter. The washers are provided to add additional support under the head of the screw in situations where the bone quality is poor. Washers are also utilized for more surface area contact with the bone which needed in order to maintain proper fixation of the fracture or osteotomy.
The Biomet Headless Compression and Twist-Off Screws are used for fixation of bone fractures, fusion of a joint, or bone reconstruction, osteotomies of the mid-foot bones, metatarsals and phalanges of the foot and metacarpals, phalanges and carpals of the hand. The Ti-6Al-4V alloy Biomet Headless Compression and Twist-Off Screws have multiple lengths and diameters associated with the different screws ranging from 2.0 to 3.0mm in diameter and lengths from 8 to 40mm. Both sets of screws will be available in sterile and non-sterile configurations. The screws include the associated essential instruments that aid in fracture fixation.
The Biomet Headless Compression Screw is a cannulated headless screw which is inserted below the bone surface. This feature helps to minimize soft tissue irritation by sitting recessed and provides compression due to a dual thread design in the shaft and head.
The Biomet Twist-Off Screw is a solid one-piece screw that has a drive shaft that has the ability to connect to a drill or large diameter pin driver. In addition, the screw incorporates a breakaway zone between the head and direct connection that allows the screw to break-off cleanly upon insertion. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.
This document describes the FDA's decision regarding the 510(k) premarket notification for several orthopedic screw systems (WasherLoc™ and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, and Biomet Headless Compression and Twist-Off Screws). The core of this submission is not about a novel AI/ML device or a device that performs diagnostic or prognostic functions based on data analysis. Instead, it's about a change in the manufacturing process (bioburden reduction) for existing, already cleared devices.
Therefore, the requested information categories related to acceptance criteria for AI performance, clinical studies, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable to this document. This submission focuses on demonstrating that a manufacturing process change does not alter the safety or effectiveness of physical medical devices.
However, I can extract the relevant information regarding the rationale for substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
Since this is a submission for a manufacturing process change for physical medical devices, acceptance criteria are generally related to the physical and biological properties of the devices after the new process, and the ability to maintain the same performance as the predicate devices. The document explicitly states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate devices |
| Indications for Use | Similar to predicate devices |
| Materials | Same as predicate devices |
| Design Features | Similar to predicate devices |
| Sterilization Method | Same as predicate devices (after the change to REVOX technology is validated) |
| Non-Clinical Tests | Assessed effects of REVOX process on Ti devices (process residuals, analytical tests like ICP-MS for metallic/nonvolatile residues); Bioburden reduction process impact on shelf life; Sterilization validation (dosage, SAL); Bacterial Endotoxin Test (non-pyrogenicity). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. This submission is not a clinical study to assess diagnostic or prognostic performance of an AI model. The "tests" mentioned are non-clinical, laboratory-based tests on the physical devices.
- The document implies that the tests performed (e.g., cytotoxicity, analytical testing, bioburden reduction, sterilization validation, BET) were conducted on the subject devices that underwent the new REVOX bioburden reduction process. No specific sample sizes for these in-vitro/bench tests are reported in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. No ground truth in the context of expert review of data is established for this type of submission. The "ground truth" for non-clinical tests would be defined by validated laboratory standards and methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for medical image interpretation or similar data is mentioned as this is a device modification submission, not a diagnostic AI clearance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. No MRMC study was performed as this is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For the non-clinical tests conducted, the "ground truth" is defined by established scientific and engineering principles, material science standards, and biological safety testing protocols (e.g., sterility assurance level (SAL), pyrogenicity limits, material composition standards).
8. The sample size for the training set:
- Not Applicable. No training set exists as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or associated ground truth.
In summary, this FDA clearance is for a change in the manufacturing process (bioburden reduction) of existing orthopedic screws, not for a new AI/ML medical device. Therefore, most of the requested information regarding AI performance criteria and studies is not relevant to this document. The "study" referenced is a series of non-clinical, laboratory-based tests to ensure the REVOX process does not negatively impact the safety and performance characteristics of the devices compared to their previously cleared versions.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.