(252 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven components. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device aids in the reattachment or fixation of torn ligaments, which is a structural repair rather than a therapeutic function.
No
Explanation: The device description and intended use clearly state that the Synthes Spiked Washer is a medical implant used for ligament reattachment or fixation. There is no mention of it being used to diagnose a medical condition or ailment.
No
The device description clearly describes a physical implantable device made of polyetheretherketone resin with specific dimensions and features (spikes, flats). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a physical implant intended for surgical use in reattaching or fixing ligaments. It is used in vivo (within the living body), not in vitro (in a test tube or lab setting).
The description clearly indicates a surgical implant, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The Spiked Washer is available in the following sizes: 8.0 mm OD / 3.2mm ID (6 spikes), 13.5 mm OD / 4.0 mm ID (8 spikes), and 13.5 mm OD / 6.0 mm ID (8 spikes). The spikes provide a link between the washer and the ligament, with flats at the base of each spike to limit penetration into the ligament and prevent excessive compression. The Spiked Washer is manufactured from a polyetheretherketone resin containing 6% barium sulfate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes (USA) Spiked Washer
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized human figure inside of a circle. To the right of the word is a small circle, which is likely a registered trademark symbol.
page 1 of 1
JAN 3 0 2002
・・・
3.0 510(k) Summary
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Thomas M. Maguire |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Spiked Washer |
| CLASSIFICATION: | Class II, Section 888.3030, Single/multiple component metallic bone
fixation appliances and accessories. |
| PREDICATE DEVICE: | Synthes (USA) Spiked Washer |
| DEVICE DESCRIPTION: | The Spiked Washer is available in the following sizes: 8.0 mm OD / 3.2mm
ID (6 spikes), 13.5 mm OD / 4.0 mm ID (8 spikes), and 13.5 mm OD / 6.0
mm ID (8 spikes). The spikes provide a link between the washer and the
ligament, with flats at the base of each spike to limit penetration into the
ligament and prevent excessive compression. The Spiked Washer is
manufactured from a polyetheretherketone resin containing 6% barium
sulfate. |
| INTENDED USE: | The Synthes Spiked Washer is intended for use in ligament reattachment or
fixation, specifically readaptation of torn or avulsed ligaments. |
| MATERIAL: | Polyetheretherketone + 6% Barium Sulfate
PEEK |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human face in profile, with three curved lines representing the hair and face. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Mr. Thomas M. Maguire Regulatory Compliance Manager Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re: K011583
Trade/Device Name: Synthes Spiked Washer Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HTN
Dated: November 2, 2001 Received: November 6, 2001
Dear Mr. Maguire:
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 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.
2
Page 2 - Mr. Thomas M. Maguire
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wilf anow you to oegin mains of substantial equivalence of your device to a legally prematics notification: "The Pro Intelling of casification 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 and 11 you desire specific arris09.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 00710 101 111 mily, for questions on the promotion and advertising of Compliance at (301) 591-1059. Free of Compliance at (301) 594-4639. Also, please note the your dones, pread combranding by reference to premarket notification" (21CFR Part 807.97). regulation on thinked, "Thisorange responsibilities under the Act may be obtained from the Other general mionnation on your new 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,
L. Mark A. Milburn
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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small circle with an R in it is located to the right of the word.
Indications for Use Statement 2.0
Page _________________________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | K011168 |
|---|---|
| --------------------------- | --------- |
Synthes (USA) Spiked Washer Device Name:
Indications/Contraindications:
Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
(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_No
Mark A. Millman
Division Sign Division of General, Restorative and Neurological Devices
KOIIS83
510(k) Number -
Confidential