K Number

Device Name

OSTEOTEC SILICONE FINGER IMPLANT

Manufacturer

OSTEOTEC LTD

Date Cleared

2015-04-17

(417 days)

Product Code

KYJ

Regulation Number

888.3230

Intended Use

Device Description

The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis. The one-piece device consists of a specifically designed, central, flexible hinge attached to an elongated rectangular-based pyramid stem on either side. The stems insert into the intramedullary canals of the metacarpals and/or phalanges and have a slight surface texture. The OSTEOTEC Silicone Finger Implant is manufactured from implant grade silicone. It is available in eleven, evenly scaled sizes to meet various anatomical requirements. The OSTEOTEC Silicone Finger Implant is not designed for use with any other devices. The implant has dedicated instrumentation which is required to prepare the bone for the implant and sizers to ensure that the correct size of product is used.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K013629

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the mechanical properties and materials of a silicone finger implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes

The device is a joint replacement implant designed to treat conditions like rheumatoid arthritis or osteoarthritis in the hand, which aligns with the definition of a therapeutic device aimed at treating or alleviating a disease or injury.

Diagnostic

This device is described as a "flexible joint replacement implant" and its purpose is to replace damaged joints, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical implant made of silicone, designed for surgical insertion into finger joints. It also mentions dedicated instrumentation and sizers, indicating a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to replace joints in the hand (MCP and PIP joints) due to conditions like rheumatoid arthritis or osteoarthritis. This is a surgical implant for treatment, not a diagnostic test performed on samples from the body.
Device Description: The description details a physical implant made of silicone, designed to be surgically inserted into the body. This is consistent with a medical device for treatment, not a diagnostic device.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

KYJ

Device Description

The one-piece device consists of a specifically designed, central, flexible hinge attached to an elongated rectangular-based pyramid stem on either side. The stems insert into the intramedullary canals of the metacarpals and/or phalanges and have a slight surface texture.

The OSTEOTEC Silicone Finger Implant is manufactured from implant grade silicone. It is available in eleven, evenly scaled sizes to meet various anatomical requirements.

The OSTEOTEC Silicone Finger Implant is not designed for use with any other devices. The implant has dedicated instrumentation which is required to prepare the bone for the implant and sizers to ensure that the correct size of product is used.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

Clastogenicity has been assessed in a mammalian system to provide data to further support the biocompatibility of the device.

Assessments of the dynamic mechanical properties, of the subject and predicate devices, via side by side flexion testing to 10 million cycles, (Size 6 and Size 00) were conducted.

Assessments of the static mechanical properties, of the subject and predicate devices, via side by side static testing of the bulk materials, (Nusil MED 4757 and Nusil MED 4755), were conducted.

Drop testing has been performed to ensure that the packaging developed for the OSTEOTEC Silicone Finger is suitable and can maintain its sterile barrier throughout storage and distribution.

A shelf life of 5 years has been established for the OSTEOTEC Silicone Finger Implant based on functional testing after sealed and irradiated packages were stored in a recommended condition for a period greater than 6 years.

The instrument tray has been validated to perform effectively during cleaning, steam sterilization and drying time.

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.

K013629

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

Regulation Number and Section

§ 888.3230 Finger joint polymer constrained prosthesis.

(a)
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.(b)
Classification. Class II.

Summary

Image /page/0/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 image of three human profiles facing to the right, with flowing lines representing hair or clothing. The profiles are stacked on top of each other, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2015

Osteotec Limited Ms. Elizabeth Clinton-Parker Quality & Regulatory Officer 9 Silver Business Park, Airfield Way Christchurch, Dorset BH23 3TA United Kingdom

Re: K140453

Trade/Device Name: OSTEOTEC Silicone Finger Implant Regulation Number: 21 CFR 888.3230 Regulation Name: Finger joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KYJ Dated: March 12, 2015 Received: March 16, 2015

Dear Ms. Clinton-Parker:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

Page 2 - Ms. Elizabeth Clinton-Parker

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Section 4 OSTEOTEC Silicone Finger Implant 510(k)

Indications for Use

510(k) number (if known): K140453

Device name: OSTEOTEC Silicone Finger Implant

Indications for use:

Prescription Use _ Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Section 4 Page 1 of 1

Section 5 OSTEOTEC Silicone Finger Implant 510(k)

510(k) Summary (in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)

1. Submitter's name and address:

Osteotec Limited 9 Silver Business Park Airfield Way Christchurch Dorset BH23 3TA U.K.

FDA Establishment Registration No. 3008395366

1. Submitter's telephone number and fax number: Tel: 011 44 1202 487885 Fax: 011 44 1202 487886
1. Contact person: Elizabeth Clinton-Parker - Auditor, QA/RA Officer
1. Date this 510(k) summary prepared: March 28, 2015
1. Trade/proprietary name of the device: OSTEOTEC Silicone Finger Implant
1. Common Name: Finger joint Polymer Constrained Prosthesis
1. Classification name and number of the device: FDA Classification Name - Finger joint polymer constrained prosthesis FDA Requlation Number - 21CFR 888.3230 FDA Product Code - KYJ
Legally marketed predicate devices to which substantial equivalence 8. is claimed:

Swanson Flexible Finger Joint Implant device is a "pre-amendment device" and is currently legally marketed in the U.S. by:

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN USA 38002

510(k) No. – Pre-amendment device FDA Decision Date - N/A FDA Device Class - 2 FDA Classification Name - Finger joint polymer constrained prosthesis FDA Regulation Number - 21CFR 888.3230 FDA Product Code - KWF

Section 5 Page 1 of 3

Section 5 OSTEOTEC Silicone Finger Implant 510(k)

Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis has been legally marketed in the U.S. since 2002 by:

Small Bone Innovations. Inc. 1380 South Pennsylvania Ave. Morrisville, PA 19067

510(k) No. K013629 FDA Decision Date – 25 January 2002 FDA Device Class - 2 FDA Classification Name - Finger joint polymer constrained prosthesis FDA Regulation Number - 21CFR 888.3230 FDA Product Code - KYJ

Description of the device that is the subject of this premarket 9. notification:

The OSTEOTEC Silicone Finger Implant is manufactured from implant grade silicone. It is available in eleven, evenly scaled sizes to meet various anatomical requirements.

10. Intended use and indication for use:

11. Technological characteristics:

The OSTEOTEC Silicone Finger Implant is manufactured from silicone implant grade Nusil MED-4757 material. The product consists of a range of 11 flexible silicone implants (sizes 00-9) intended for ioint replacements of the MCP and PIP joints of the hand.

12. Substantial Equivalence Determination

The direct patient contacting material of the OSTEOTEC Silicone Finger lmplant is the silicone supplied by Nusil as product code MED-4757.

Section 5 Page 2 of 3

Section 5 OSTEOTEC Silicone Finger Implant 510(k)

Clastogenicity has been assessed in a mammalian system to provide data to further support the biocompatibility of the device.

Assessments of the dynamic mechanical properties, of the subject and predicate devices, via side by side flexion testing to 10 million cycles, (Size 6 and Size 00) were conducted.

Assessments of the static mechanical properties, of the subject and predicate devices, via side by side static testing of the bulk materials, (Nusil MED 4757 and Nusil MED 4755), were conducted.

Drop testing has been performed to ensure that the packaging developed for the OSTEOTEC Silicone Finger is suitable and can maintain its sterile barrier throughout storage and distribution.

The instrument tray has been validated to perform effectively during cleaning, steam sterilization and drying time.

Based on the results from the above test data it is concluded that the OSTEOTEC Silicone Finger Implant is substantially equivalent to the above named predicate devices.

Section 5 Page 3 of 3