The Synthes Metallic Spiked Washers are washers of various sizes with metal spikes arrayed around a center hole.
The Synthes Spiked Washers are available in either implant quality 316L stainless steel or CP titanium. The washer for use with 2.7 mm screws has an inner diameter of 3.2 mm and an outer diameter of 9.0 mm. The washer for use with 3.5 mm and 4.0 mm screws has an inner diameter of 4.0 mm and an outer diameter of 13.5 mm. The washer for use with 4.5 mm and 6.5 mm screws has an inner diameter of 5.5 mm and an outer diameter of 13.5 mm. The smaller washer has six spikes while the two larger washers with an outer diameter of 13.5 mm both have eight spikes.

AI/ML Overview

The provided document, K013806, is a 510(k) Premarket Notification for the Synthes Metallic Spiked Washers, dated February 8, 2002. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a new clinical trial with specific performance criteria.

Therefore, the document does not contain acceptance criteria or a study designed to prove the device meets such criteria.

Here's why and what information is provided:

Substantial Equivalence: The core of a 510(k) is to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new characteristics do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
No Specific Performance Study: The document explicitly states: "Documentation was provided which demonstrated the Synthes Metallic Spiked Washers to be substantially equivalent to other legally marketed devices." It does not describe a performance study with acceptance criteria as would be found in a PMA (Premarket Approval) submission or a device undergoing clinical trials to establish its efficacy and safety against predefined metrics.

Based on the provided text, the following information cannot be extracted:

A table of acceptance criteria and the reported device performance: Not applicable for a 510(k) submission focused on substantial equivalence.
Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Information that is available in the document:

Device Name: Synthes Metallic Spiked Washers
Indications for Use: The Synthes Metallic Spiked Washers are indicated for ligament reattachment or fixation.
Materials: Stainless Steel and Titanium (either implant quality 316L stainless steel meeting ASTM F138 or CP Titanium meeting ASTM F67).
Device Description: Washers of various sizes with metal spikes arrayed around a center hole.
- Washer for 2.7 mm screws: inner diameter 3.2 mm, outer diameter 9.0 mm, six spikes.
- Washers for 3.5 mm and 4.0 mm screws / 4.5 mm and 6.5 mm screws: inner diameter 4.0 mm / 5.5 mm, outer diameter 13.5 mm, eight spikes.
Predicate Devices: Synthes Spiked Washer (K971447) and Synthes Titanium Locked Spiked Washer (K972778), highlighting similar indications, modifications, features, and size ranges.
Sterilization: Provided either sterile or non-sterile. Non-sterile devices must be sterilized before use (parameters in Attachment I(b)), with steam sterilization recommended for a Sterility Assurance Level (SAL) of 10^-6. Intended for single use only.

Essentially, a 510(k) submission largely relies on comparing the new device against existing, cleared devices rather than conducting new performance studies with detailed acceptance criteria and ground truth establishment.

Summary

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K013806

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FEB 0 8 2002

Summary of Safety and Effectiveness Information 3.

Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301
Company Contact	Matthew M. Hull(610) 647-9700 ext. 7191
Name of the Device	Synthes Metallic Spiked Washers
Device Classification(s)	Class II, §888.3030 -- Washer, bolt, nut, non-spinal
Substantial Equivalence	Documentation was provided which demonstrated the SynthesMetallic Spiked Washers to be substantially equivalent to otherlegally marketed devices.
Device Description	The Synthes Metallic Spiked Washers are washers of various sizeswith metal spikes arrayed around a center hole.
Indications	The Synthes Metallic Spiked Washers are indicated for ligamentreattachment or fixation.
Materials	Stainless Steel and Titanium

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-K013806

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Device Name 4.

Proprietary Name: Synthes Metallic Spiked Washers Common Name: Spiked Washers Classification Name: Washer, Bolt, Nut, Non-spinal

Manufacturer Identification પં

The devices subject to this Premarket Notification will be manufactured by Synthes (USA), I ne devices subject to allo Frit, Colorado 80132 (FDA Registration #1719045).

Classification Information 6.

The classification of the Synthes Metallic Spiked Washers are Class II, as per Title 21 of the I he classification of the Synnes Meanie Spaled witiple component metallic bone fixation appliances and accessories. The device Product Code is HTN.

Information Relating to Performance Standards and Special Controls 7.

The Synthes Metallic Spiked Washers will be manufactured from either implant quality 316L The Synthes Mecame Bplkco Trailers TP Titanium meeting ASTM F67. Synthes is not aware stanness stool mooting - sandards or special controls established to this date.

Sterilization Information 8.

Synthes will provide the device either sterile or non-sterile. Sterilization information for the Synules will provide the device citierent I(a). Non-sterile devices must be sterilized prior to use; sterite device can be found in Attachine the parameters identified in Atlachment I(D). mors neat stermization is recommended assure a Sterility Assurance Level (SAL) of 10 °. This device is intended for single use only.

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KO13806 3 of 3

9. Description of the Device

The Synthes Spiked Washers are available in either implant quality 316L stainless steel or CP r he bynnies Bpixod washer for use with 2.7 mm screws has an inner diameter of 3.2 mm and an outer thannum. The washer for use with 3.5 mm and 4.0 mm screws has an inner diameter diameter of 0.0 mm - 110 washer of 13.5 mm. The washer for use with 4.5 mm and 6.5 mm of 4.0 mm and an outer diameter of 5.5 com and an outer diameter of 13.5 mm. The smaller washer serows has an miller diameter has six spikes while the two larger washers with an outer diameter of 13.5 mm both have eight spikes.

Confidential engineering drawings of the Synthes Metallic Spiked Washers can be found in Attachment II.

Proposed Labels and Labeling 10.

Proposed labels and labeling for this device can be found in Attachment III.

Commercially Available Device Information 11.

The predicate devices for the Synthes Metallic Spiked Washer are the Synthes Spiked Washer The Synthes Titanium Locked Spiked Washer which were cleared via 510(k) premarket allu the Synthes Thanam Docked by St respectively. All these devices have the same indications, nontications #12714472 and #1272 have similar features, and are available in a similar range of sizes. Information on the predicate devices can be found in Attachment IV.

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Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle symbol, with three curved lines representing the eagle's wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 8 2002

Mr. Matthew M. Hull, RAC Senior Regulatory Associate Synthes 1690 Russell Road Paoli. Pennsylvania 19301

Re: K013806

Trade Name: Synthes Metallic Spiked Washers Regulation Number: 888.3030 Regulation Name: Washer, bolt, nut, non-spinal Regulatory Class: II Product Code: HTN Dated: November 9, 2001 Received: November 15, 2001

Dear Mr. Hull:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becareermined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to mulcations for use succe in the Medical Device Amendments, or to devices that have May 20, 1970, and chargers and the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, (Act) that do not require apper to the general controls provisions of the Act. The general therefore, manor the Act include requirements for annual registration, listing of devices, Controls provisions or active, 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 If your device is elabilional controls. Existing major regulations affecting your device can may or sabject to back as a sateral Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou louits 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 that FDA has made a determination that your device complies with other requirements of the Act that I Dr has Internations and regulations administered by other Federal agencies. You must or any I oceral bahates and a 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.

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Page 2 -- Mr. Matthew Hull

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin maing of substantial equivalence of your device to a legally premits to the are 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 and II you desire specific advice to: you invitro diagnostic devices), please contact the Office of additionally 21 CFR Furt 007. I additionally, for questions on the promotion and advertising of Compliance at (301) 594-1000 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation chitica, "Misoranang of responsibilities under the Act may be obtained from the Other general information on your respectional 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 N. 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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K013806

Indications for Use Statement 2.

510(k) Number (if known):

Device Name:

Indications for Use:

Synthes Metallic Spiked Washers

The Metallic spiked washers are indicated for ligament reattachment or fixation.

(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

CONFIDENTIAL

Over-The-Counter Use_

Mark N. Mulkers

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013806

Synthes(USA) Synthes Metallic Spiked Washers 510(k)

000000

Regulation Number and Section

§ 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.