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The TCP System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. Specific examples include:

Mid / Hindfoot 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-Cuboid (CC) Fusion
• Medial Column Fusion

First metatarsal osteotomies for hallux valgus correction including:

• · 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)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• · Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• · Revision MTP Fusion
• · Revision of failed first MTP Arthroplasty implant

Flatfoot Osteotomies

• · Lateral Column Lengthening (Evans Osteotomy)
• · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

The TOTAL COMPRESSION PLATING SYSTEM is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. Most of the plates are scalloped in shape to allow easier bending to fit the contour of the bone. There are also nonscalloped plates to provide greater strength. The plates include straight, right, and left configurations.

This document is a 510(k) premarket notification for a medical device called the TOTAL COMPRESSION PLATING (TCP) SYSTEM. Based on the provided text, there is no study described that involves acceptance criteria for device performance in the context of AI or diagnostic accuracy.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for marketing purposes. It states:

1. No specific acceptance criteria or device performance data are reported. The submission relies on the fact that "The subject TOTAL COMPRESSION PLATING SYSTEM design is identical to the currently marketed TOTAL COMPRESSION PLATING SYSTEM."
2. No sample size for a test set, data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance are described. This type of information is pertinent to studies evaluating AI or diagnostic device accuracy, which is not the nature of this submission.
3. The ground truth discussions (for training or test sets) are not relevant here as this is not an AI or diagnostic device.
4. No sample size for the training set is mentioned.

Instead, the document refers to:

• Mechanical testing and engineering analysis that "was previously provided in the predicate device filings. Therefore, no testing was provided for the subject device as the design is identical." This implies that the 'acceptance criteria' for this type of device would typically relate to mechanical properties (e.g., strength, durability, biocompatibility) rather than diagnostic accuracy.
• Non-Clinical Evidence as the basis for substantial equivalence, with "N/A" for "Substantial Equivalence Clinical Evidence."

In summary, this 510(k) submission establishes substantial equivalence for a bone fixation plating system by demonstrating that its design is identical to a previously cleared predicate device, and thus relies on the prior mechanical testing and engineering analysis of that predicate. It does not contain information related to acceptance criteria or studies proving performance in the context of accuracy, reader improvement, or AI systems.

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