The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with other previously cleared femoral components including the Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457) for uncemented primary or revision hemi-arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

Femoral neck and trochanteric fractures of the proximal femur .
Osteonecrosis of the femoral head .
Revision procedures where other treatments or devices or these indications have failed.

Device Description

The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with the previously cleared femoral components including Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457)). The Ring-Lok™ Modular Bipolar System consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 62 mm, in 1mm increments, to properly fit the patient anatomy. The inner diameter mates with a 22.225, 26 or 28 mm diameter femoral head.
Implant International supplies Ring-Lok™ Bi-Polar Instrumentation for use with the Ring-Lok™ Modular Bi-Polar System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ring-Lok™ Modular Bipolar System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Range of Motion	Performance substantially equivalent to predicate devices.	Met all acceptance criteria.
Lever Out	Performance substantially equivalent to predicate devices.	Met all acceptance criteria.
Pull Out	Performance substantially equivalent to predicate devices.	Met all acceptance criteria.
Overall Performance	As safe, effective, and performs as well as or better than predicate devices.	Substantially equivalent to predicate devices.

Note: The document states that the testing was "to written protocols with pre-defined acceptance criteria," but it does not explicitly list the quantitative acceptance criteria for each test beyond requiring substantial equivalence to predicate devices. The reported performance consistently states that the criteria were met.

2. Sample Size for Test Set and Data Provenance

Sample Size: "worst case component size and option/design." The exact number is not specified, but it implies a focused selection of the most challenging configurations for testing.
Data Provenance: The testing was conducted by Implant International Limited, based in the UK. Therefore, the data provenance is likely UK-based, non-clinical (laboratory), and prospective (as it was part of design verification for this specific device).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The testing described is non-clinical performance testing (mechanical/engineering tests), not clinical studies involving human patients or expert interpretation of clinical data. Therefore, the concept of "ground truth" established by medical experts for a test set in the usual sense does not apply here.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As explained above, the tests are non-clinical engineering evaluations, not clinical data requiring adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical performance test comparing the device to predicate devices through engineering evaluations.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to this medical device. The "Ring-Lok™ Modular Bipolar System" is a physical implant (a hip prosthesis component), not an AI algorithm or software. Therefore, there's no "algorithm only" or "human-in-the-loop" performance to evaluate in this context. The standalone performance refers to the device itself performing its intended biomechanical function without direct human intervention during its operation in the body.

7. Type of Ground Truth Used

The "ground truth" in this context is the performance of established predicate devices (Medacta Bi-Polar Head K091967 and BioPro Bi-Polar Head K082705) in similar non-clinical tests, and the engineering specifications/standards that these types of devices are expected to meet. The aim was to demonstrate "substantial equivalence" to these predicates.

8. Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms, which is not what this device is.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the reasons stated in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo for "Implants International". The logo consists of a circle with a dot on top and the text "IMPLANTS INTERNATIONAL" to the right of the circle. The text is in a simple, sans-serif font.

K132539 Page 1/3

FEB - 7 2014

510(k) Summary

K132539

Ring-Lok™ Modular Bipolar System

31 January 2014

Implants International Limited Trudie Seeger, PhD 1. Submitter: Contact: 71 Jay Avenue U.S. Agent Teeside Industrial Estate 614-876-6374(p) Thornaby-on-Tees, TS17 9LZ UK 614-876-6621(f)

2. Device Name

Proprietary Name: Ring-Lok™ Modular Bipolar System Common Name: Hemi-hip prosthesis, uncemented Classification Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Class II per 21 CFR §888.3390 (Product Code Regulatory Class: KWY)

3. Indication for Use

The Ring-Lok Hip System Bipolar Head is intended for use in combination with other previously cleared femoral components including the Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457)) for uncemented primary or revision hemi-arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

. Femoral neck and trochanteric fractures of the proximal femur
. Osteonecrosis of the femoral head
Revision procedures where other treatments or devices or these indications have failed. .

Page 9 of 26

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with a circular design on the left and text on the right. The circular design has a dark semicircle at the top and some lines inside the circle. To the right of the circle, the text reads "IMPLA" on the first line and "INTERNATIONAL" on the second line. The text is in a simple, sans-serif font.

K132539 Page 2/3

4. Device Description

Implant International supplies Ring-Lok™ Bi-Polar Instrumentation for use with the Ring-Lok™ Modular Bi-Polar System.

5. Predicate Device Comparison

Substantial equivalence is claimed to the Medacta Bi-Polar Head (K091967) and the BioPro Bi-Polar Head (K082705). The Ring-Lok ™ Modular Bipolar System:

ls the same technology (design and material) as the predicate devices .
Has the same or similar Indication for Use as the predicate devices .
Has the same functionality as the predicate devices .
Includes the same bipolar head inner and other dimensional sizes as the predicate . devices
Allows the head to snap-fit into the bipolar liner which is the same as one of the . predicate devices (BioPro Bi-Polar Head)

Nonclinical Performance Testing 6.

The Ring-Lok™ Modular Bipolar System was tested as part of design verification to written protocols with pre-defined acceptance criteria. Testing included Range of Motion, Lever Out and Pull Out tests conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that the performance of the Ring-Lok ™ Modular Bipolar System is substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo and some text. The logo is a circle with the words "IMPLANTS INTERNATIONAL" written inside. The text "K132539 Page 3/3" is written in the top right corner of the image. The logo is on the left side of the image.

7. Conclusion

The information provided in this premarket notification demonstrates that the Ring-Lok™ Modular Bipolar System is as safe, as effective and performs as well as or better than the predicate devices, Medacta® Bi-polar Head and Bi-Pro Bipolar Head. This information supports the conclusion that Ring-Lok™ Modular Bipolar System is substantially equivalent to its predicate devices, with respect to intended use, design and operational principles.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font.

Public Health Service

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

February 7, 2014

Implant International Limited % Trudie L. Seeger, Ph.D. United States Agent T. Leland Seeger & Associates 4170 Bowmansroot Court Hilliard. Ohio 43026

Re: K132539

Trade/Device Name: Ring-Lok" Modular Bi-Polar System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY Dated: January 2, 2014 Received: January 6, 2014

Dear Dr. Seeger:

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 (21

{4}------------------------------------------------

Page 2 - Trudie L. Seeger, Ph.D.

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Small Manufacturers, International and Consumer Assistance 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

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K132539

Device Name:

Ring-Lok™ Modular Bi-Polar System

Indications for Use:

Femoral neck and trochanteric fractures of the proximal femur .
Osteonecrosis of the femoral head .
Revision procedures where other treatments or devices or these indications have failed. �

Prescription Use

(21 CFR 801 Subpart D)

and/or Over-The-Counter Use

(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)

Elizabethaa Frank -S

Page 1 of __

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.