(103 days)
Percutaneous Compression Wire system for the fixation of osseous fragments or fractures of small bones, including:
- Scaphoid fractures
- Lunate fractures
- Capitate
- Carpal fractures & non-unions
- Capitellum fractures
- Humeral head fractures
- Trapezial fractures
- Metacarpal and metatarsal fractures
- Phalangeal fractures
- Distal radial fractures
- Ulnar styloid fractures
- Osteo-chrondral fractures
- Small joint fusions
- Glenoid fractures
- Intercarpal fusions
- Interphalangeal fractures
- Metatarsal osteotomies
- Tarsal fusions
- Malleolar fractures
- Hammer toe fixation
The PCW" is supplied as a single length threaded stainless steel wire or pin. The pin is selftapping and self-cutting and does not vary in length or diameter. The engineering drawings include diameter and length information. However, the pins are nominally six inches in length and fifty-nine thousandths diameter. The pins are intended for small bone applications (fractures and osteotomies) including distal fragments of long bones. The principal areas of use are the upper extremity and the hands and feet. The pins may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible. The primary use of the wires is percutaneous, that is, without the need for an external fixatior as in the case of "hammer-toes" or similar phlangeal or small bone losteotomies. The secondary use of the wires is in association with the use of an external fixation device as a means to secure and fix small fragments until healing is complete. MMT supplies instrumentation designed specifically to interface with this implant system. Their use of general manual orthopaedic instrumentation is not recommended for the insertion of this device. The screws are made from stainless steel alloy.
The provided text describes a medical device, the PCW™ Percutaneous Compression Wire, and its 510(k) premarket notification. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document focuses on:
- Device Identification: Trade name, common name, classification, establishment information.
- Regulatory Compliance: References to ISO standards (ISO 9001-2000, ISO-5832-3,1996(E)) for manufacturing and materials, and general controls for Class II devices.
- Labeling: Warning and caution statements.
- Equivalent Devices: Comparison to predicate devices (Synvasive k-wires, Miltex Steinmann pins) based on basic design, features, and intended use.
- Device Description: Material (316 LVM, ASTM F138), dimensions, and general application (small bone fractures and osteotomies).
- Intended Use: A comprehensive list of specific fracture types and fusions for which the device is intended.
- FDA Communication: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices and authorizing marketing, subject to general controls.
Key Missing Information:
The document does not include:
- Quantitative acceptance criteria for device performance.
- Details of any performance study (e.g., mechanical testing, clinical trials, usability studies).
- Data provenance, sample sizes, or expert qualifications for any testing.
- Information on MRMC studies or standalone algorithm performance.
- The type or establishment of ground truth for any evaluation.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary details are not present in the provided text. The FDA's substantial equivalence determination for this device relies on its similarity to existing, legally marketed predicate devices, implying that its performance is implicitly accepted as equivalent to those devices, rather than through a new, explicit performance study described in this submission.
§ 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.