(73 days)
The Multi-Use Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
-Mono or Bi-Cortical osteotomies in the foot or hand
-Distal or Proximal metatarsal or metacarpal osteotomies
-Weil osteotomy
-Fusion of the first metatarsophalangeal joint and interphalangeal joint
-Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
-Akin type osteotomy
-Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
-Calcaneus/ cuboid arthrodesis
-talar/ navicular arthrodesis
The design features of the Multi-Use Compression Screw are summarized below:
- Manufactured from Stainless Steel .
- Offered in two diameters: 3.0mm and 4.3mm .
- Offered in lengths ranging from 10mm-60mm .
- Offered in two thread lengths: short and long .
- Self drilling and self tapping features on both distal and proximal . threads
- Proximal threaded head is fully recessed into bone to allow for a zero . profile once fully inserted
The provided text describes the 510(k) summary for the Multi-Use Compression Screw, which is a medical device for bone fixation. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the provided text.
The document does not describe an AI/ML device, a study with human readers, or a ground truth established by experts/pathology for image analysis. Instead, it describes a mechanical bone fixation screw and its substantial equivalence to previously cleared predicate devices through direct comparison and mechanical testing. Therefore, many of the requested fields are not applicable.
Acceptance Criteria and Device Performance
The acceptance criteria for the Multi-Use Compression Screw are implicitly derived from demonstrating substantial equivalence to existing legally marketed predicate devices, specifically the Newdeal BOLD® Compression Screw and the Newdeal I.CO.S.® Screw. The performance is measured by conformance to an ASTM standard, which assesses mechanical properties relevant to its intended use.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition Equivalence: Manufactured from materials equivalent to predicate devices. | Manufactured from Stainless Steel. The document states: "The design features, material, and indications for use of the Multi-use Compression Screw are substantially equivalent to the previously cleared Newdeal BOLD® Compression Screw and the Newdeal I.CO.S.® Screw." This implies the material meets equivalence. |
| Design Feature Equivalence: Similar design features (diameters, lengths, thread types, self-drilling/tapping, recessed head) to predicate devices. | "Offered in two diameters: 3.0mm and 4.3mm." "Offered in lengths ranging from 10mm-60mm." "Offered in two thread lengths: short and long." "Self drilling and self tapping features on both distal and proximal threads." "Proximal threaded head is fully recessed into bone to allow for a zero profile once fully inserted." These features are presented as being substantially equivalent to the predicate devices. |
| Intended Use Equivalence: Indications for use are the same as predicate devices. | The Indications for Use section lists specific bone fracture and reconstruction procedures, which are stated as substantially equivalent to the predicate devices. |
| Mechanical Performance: Confirms to relevant performance standards for bone fixation screws. | Confirmed by testing conforming to ASTM 543-02. The document states: "The safety and effectiveness of the Multi-use Compression Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of an algorithm's performance on human data (e.g., images). Instead, it refers to mechanical testing.
- The sample size for the mechanical testing (conforming to ASTM 543-02) is not explicitly stated. ASTM standards themselves often specify minimum sample sizes for different tests, but this specific number is not provided in the 510(k) summary.
- Data Provenance: The "data" refers to the results of mechanical tests performed on the Multi-Use Compression Screw. The document does not specify a "country of origin" for this data, but the submission is from Wright Medical Technology, Inc., located in Arlington, Tennessee, USA. The testing would have been conducted by or for the manufacturer. It is a prospective test in the sense that the new device was manufactured and then tested to the ASTM standard.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, not an AI/ML device requiring expert-labeled ground truth from data like images. The "ground truth" for a mechanical screw's performance is established by objective engineering standards and physical measurements as per ASTM 543-02.
-
Adjudication method for the test set:
- Not Applicable. No human adjudication of data for ground truth was performed or required as this is a mechanical device with performance evaluated against a standard.
-
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 is not an AI/ML device, and no human reader study was conducted.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm. Standalone performance for a mechanical screw relates to its intrinsic physical and mechanical properties, which were assessed via the ASTM standard.
-
The type of ground truth used:
- For a mechanical device like this, the "ground truth" is defined by established engineering standards and physical measurements. Specifically, the device's mechanical properties (e.g., strength, torque, fatigue resistance) are compared against the requirements specified in ASTM 543-02. The successful compliance with this standard serves as the "ground truth" for its mechanical performance and substantial equivalence.
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth to establish in this context.
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K043/02
JAN 2 1 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Multi-use Compression Screw.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | November 4, 2004 |
| Contact Person: | Wesley L. ReedRegulatory Affairs Specialist |
| Proprietary Name: | Multi-Use Compression Screw |
| Common Name: | Bone Fixation Screw |
| Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener - Class II |
| Device Product Code and Panel Code: | 21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener - Class II |
DEVICE INFORMATION
A. INTENDED USE
The Multi-Use Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
-Mono or Bi-Cortical osteotomies in the foot or hand
-Distal or Proximal metatarsal or metacarpal osteotomies
-Weil osteotomy
-Fusion of the first metatarsophalangeal joint and interphalangeal joint
-Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
-Akin type osteotomy
-Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
-Calcaneus/ cuboid arthrodesis
-talar/ navicular arthrodesis
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B. DEVICE DESCRIPTION
The design features of the Multi-Use Compression Screw are summarized below:
- Manufactured from Stainless Steel .
- Offered in two diameters: 3.0mm and 4.3mm .
- Offered in lengths ranging from 10mm-60mm .
- Offered in two thread lengths: short and long .
- Self drilling and self tapping features on both distal and proximal . threads
- Proximal threaded head is fully recessed into bone to allow for a zero . profile once fully inserted
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the Multi-use Compression Screw are substantially equivalent to the previously cleared Newdeal BOLD® Compression Screw and the Newdeal I.CO.S.® Screw. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the Multi-use Compression Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
Mr. Wesley L. Reed Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K043102
Trade/Device Name: Multi-Use Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 5, 2004 Received: November 9, 2004
Dear Mr. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de rices mat have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, dicrerere, market of the Act include requirements for annual registration, listing of general controls pro resuring practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device is elassified (overal controls. Existing major regulations affecting your device can may be our leases to cases as Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be act not a a determination that your device complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must of any I occur statutes and regisments, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Wesley L. Reed
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification: "The PPF mailing of cation for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice ice your 240) 276-0115. Also, please note the regulation entitled, Connact the Ories of Come of Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Multi-Use Compression Screw
Indications For Use:
The Multi-Use Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
-Mono or Bi-Cortical osteotomies in the foot or hand
-Distal or Proximal metatarsal or metacarpal osteotomies
-Weil osteotomy
-Frsion of the first metatarsophalangeal joint and interphalangeal joint -Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
-Akin type osteotomy
-Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
-Calcaneus/ cuboid arthrodesis
-talar/ navicular arthrodesis
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Use
rt C)
No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Division of General. Restorative, and Neurological Devices
510(k) Number K043102
1 of 1
§ 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.