(55 days)
Synthes Combination Clamp and Dynamization Clip – MR Safe are generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for:
- Stabilization of soft tissue injuries and open or closed fractures;
- Polytrauma;
- Vertically stable pelvic fractures as a treatment adjunct for vertically unstable pelvic fractures;
- Arthrodesis and osteotomies with soft tissue problems;
- Failures of total joints;
- Neutralization of fractures stabilized with limited internal fixation;
- Non-unions;
- Intraoperative reduction/stabilization tool to assist with indirect reduction;
- Unilateral rectilinear bone segment transport or leg lengthening.
Synthes Large Combination Clamp and Dynamization Clip-MR Safe are components of an external fixation frame that forms a construct intended to treat long bone and pelvic fractures. The Dynamization Clip is an accessory to the clamp that allows dynamization during bone healing. These devices are intended for use in the MR environment. Frame components accept Synthes Ø11.0 mm carbon fiber rods and Synthes Schanz screws in diameters of 4 - 6 mm.
The provided text is a 510(k) summary for the "Synthes Large Combination Clamp and Dynamization Clip – MR Safe." It describes the device's intended use, materials, and classification, and states that it has been determined to be substantially equivalent to a predicate device.
However, the provided text DOES NOT contain information about acceptance criteria, device performance testing (including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), or the training set for any AI/ML model.
This document is a regulatory submission for a physical medical device (an external fixation clamp) and not an AI/ML-driven device. Therefore, the questions related to AI/ML model performance, ground truth, and training/test set details are not applicable to the content provided.
The text focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. For such devices, performance is typically assessed through aspects like:
- Material compatibility: Ensuring the selected materials are biocompatible and suitable for medical use.
- Mechanical strength/durability: Testing the physical integrity and load-bearing capacity of the device under simulated physiological conditions.
- Sterilization validation: Confirming that the device can be effectively sterilized without degradation.
- MR Safety evaluation: Demonstrating that the device is safe for use in magnetic resonance environments (which is explicitly stated in the device name "MR Safe").
Without the specific test reports or performance data that would have been submitted alongside this 510(k) summary, it's impossible to describe the acceptance criteria and study details requested in the prompt.
{0}------------------------------------------------
APR 0 1 2003
30390
Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Contact: Bonnie Smith | |
| Device Name: | Synthes Large Combination Clamp and Dynamization Clip – MR Safe |
| Classification: | Class II, 21 CFR 888.3030: "Single/multiple component bone fixationappliances and accessories." |
| Predicate Device: | Synthes Combination Clamp and Dynamization Clip |
| Device Description: | Synthes Large Combination Clamp and Dynamization Clip-MR Safe arecomponents of an external fixation frame that forms a construct intended totreat long bone and pelvic fractures. The Dynamization Clip is an accessoryto the clamp that allows dynamization during bone healing. These devicesare intended for use in the MR environment. Frame components acceptSynthes Ø11.0 mm carbon fiber rods and Synthes Schanz screws indiameters of 4 - 6 mm. |
| Intended Use: | Synthes Combination Clamp and Dynamization Clip – MR Safe aregenerally intended to be used in the construction of an external fixationframe to treat long bone and pelvic fractures. Specifically, the SynthesCombination Clamp with Dynamization Clip is intended for:■ Stabilization of soft tissue injuries and open or closed fractures;■ Polytrauma;■ Vertically stable pelvic fractures of as a treatment adjunct forvertically unstable pelvic fractures;■ Arthrodesis and osteotomies with soft tissue problems;■ Failures of total joints;■ Neutralization of fractures stabilized with limited internal fixation;■ Non-unions/septic non-unions;■ Intraoperative reduction/stabilization tool to assist with indirect reduction;■ Unilateral rectilinear bone segment transport or leg lengthening. |
| Materials: | Clamps - Stainless steel, titanium alloy and cobalt alloyDynamization Clip - Cobalt alloy |
3.0
510(k) Summary
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 1 2003
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
Re: K030390
Trade/Device Name: Synthes Large Combination Clamp and Dynamization Clip - MR Safe Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: February 4, 2003 Received: February 5, 2003
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
{2}------------------------------------------------
Page 2 -- Ms. Bonnie J. Smith
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Milhurn
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
{3}------------------------------------------------
Page of
510(k) Number (if known):
Device Name:
INDICATIONS:
Image /page/3/Picture/5 description: The image shows a document with the title "Division Sign-Off" and the subtitle "Division of General, Restorative and Neurological Devices". The document also includes the text "510(k) Number" followed by the number "K050390". There is a signature above the title, which appears to read "Mark Miller".
Ko30390
Synthes (USA) Synthes Large Combination Clamp and Dynamization Clip - MR Safe
Synthes Combination Clamp and Dynamization Clip - MR Safe are generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for:
- · Stabilization of soft tissue injuries and open or closed fractures;
-
- Polytrauma;
- · Vertically stable pelvic fractures as a treatment adjunct for vertically unstable pelvic fractures;
- . Arthrodesis and osteotomies with soft tissue problems;
- · Failures of total joints;
- · Neutralization of fractures stabilized with limited internal fixation;
- · Non-unions;
- · Intraoperative reduction/stabilization tool to assist with indirect reduction;
- · Unilateral rectilinear bone segment transport or leg lengthening.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Premarket Notification 510(k): CONFIDENTIAL Synthes (USA) Large Combination Clamp and Dynamization Clip - MR Safe
0004
§ 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.