(56 days)
The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the system can be used in both adult and pediatric patients. In the foot, the system can be used for the following specific examples:
- First metatarsal osteotomies for hallux valgus correction such as:
- · Opening base wedge osteotomy
- · Closing base wedge osteotomy
- · Crescentic osteotomy
- Proximal Chevron osteotomy
- · Distal Chevron osteotomy (Austin)
- First metatarsal fracture fixation
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- Flatfoot Osteotomies
- · Lateral Column Lengthening (Evans Osteotomy)
- · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton
- Osteotomy)
- Mid / Flatfoot Fusions
- · LisFranc Arthrodesis and/or Stabilization
- · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- · Navicular-Cuneiform (NC) Fusion
- · Talo-Navicular (TN) Fusion
- Calcaneo-Cubiod (CC) Fusion
- Medial Column Fusion
- Arthrodesis of the first metatarsophalangeal joint (MTP)
This traditional 510(k) is to obtain clearance for expanded indications for the Treace Medical Concepts (TMC) Plating System implants. The subject TMC Plating System implants include a variety of previously cleared bone plates and screws. The plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136.
The Treace Medical Concepts (TMC) Plating System is a medical device intended for stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet in both adult and pediatric patients.
Acceptance Criteria and Device Performance:
Since this submission aimed to expand the indications for use to include pediatric patients and the device itself (implants) had been previously cleared in other 510(k)s, no new performance testing was provided for this specific submission (K183321). This is explicitly stated: "Performance testing was not required to support the expanded indications for the subject device." The substantial equivalence determination was based on the similarity of the revised indications to those of predicate devices that already included pediatric use.
Therefore, for this specific 510(k) submission, a table of acceptance criteria and reported device performance (in terms of specific quantitative outcomes like accuracy, sensitivity, specificity, etc.) is not applicable as no new performance testing was conducted or provided to prove the device meets new acceptance criteria. The acceptance was based on demonstrating substantial equivalence to already cleared devices with similar expanded indications.
Details of the Study (or lack thereof for this submission):
-
1. A table of acceptance criteria and the reported device performance: Not applicable for this specific submission as no new performance testing was conducted. The acceptance was based on substantial equivalence.
-
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new test set data was provided.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set was used.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set was used.
-
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. This device is a plating system, not an AI-assisted diagnostic or treatment planning tool.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a plating system.
-
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No new ground truth data was generated for this submission. The substantial equivalence was based on existing predicate devices.
-
8. The sample size for the training set: Not applicable. This device is a plating system, not an AI/machine learning device requiring a training set.
-
9. How the ground truth for the training set was established: Not applicable. This device is a plating system.
§ 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.