The PROCOTYL® L-O Acetabular System is intended for use in total hip arthroplasty for reduction or relief of pain and/ or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and.
revision procedures where other treatments or devices have failed

The PROCOTYL® L-O Acetabular System utilizes single use components. intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.

Device Description

The PROCOTYL® L and O acetabular cup designs are based off the LINEAGE™ Acetabular System (K002149) which was designed from the TRANSCEND® product line. The subject PROCOTYL® acetabular system of this submission includes the PROCOTYL® L Acetabular Cup, the PROCOTYL® O Acetabular Cup, RIM-LOCK "A-CLASS®" Acetabular Poly Liner and BIOLOX® delta Ceramic Femoral Head.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: PROCOTYL® L-O Acetabular System (Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis)

Based on the provided document, the device approval is based on substantial equivalence to predicate devices, not on a study proving it meets specific, predefined acceptance criteria for novel performance. Therefore, many of the requested categories will be answered with "Not Applicable" or similar.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from the document)	Reported Device Performance (from the document)
Mechanical/Physical Performance:
Static Compression to Failure	Evaluated per ISO 7206-10. Device was "deemed acceptable."
Range of Motion	Evaluated per ISO 21535. Device was "deemed acceptable."
Material Equivalence:
Material (general)	Identical Titanium Alloy, Ti6Al4V, wrought or forged (ASTM F136 or ASTM F620 respectively) as the predicate device.
Coating	Identical titanium plasma spray coating (ASTM F1580) or beaded coating (ASTM F1580/F67) as the predicate device.
Functional Equivalence:
Indications for Use	Identical to those for the predicate devices (K130376 and K140043 for heads; K002149 for shells/liners).
Fundamental Scientific Technology	Identical to those of the predicate devices.
Design Features	Substantially equivalent to those of the predicate devices (based on design from a referenced product line and similar predicate designs, e.g., LINEAGE™ Acetabular System, TRANSCEND® product line, DYNASTY® Acetabular System).

Note: The document explicitly states that "Clinical data was not provided for the subject devices." This significantly impacts the answers to the following questions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable (No clinical test set was used/provided). For non-clinical testing, specific sample sizes for tests like static compression or range of motion are not detailed, only that the tests were conducted.
Data provenance: Not applicable (No clinical data provided). For non-clinical, it's typically lab-based testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable (No clinical test set or ground truth determination by experts was described in the provided document).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable (No clinical test set requiring adjudication was described).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable (This device is a physical hip implant, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable (This is a physical medical device, not an algorithm or AI system).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable (No clinical ground truth was established, as no clinical data was provided). For non-clinical tests, the "ground truth" is typically defined by the standards (ISO 7206-10, ISO 21535) and the mechanical properties observed.

8. The sample size for the training set

Not applicable (No training set was used, as this is a physical device submission based on substantial equivalence, not a machine learning model).

9. How the ground truth for the training set was established

Not applicable (No training set was used).

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a way that suggests unity and connection. The profiles are black and are set against a white background. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

February 27, 2015

MicroPort Orthopedics, Inc. Mr. Byron Ledbetter Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K142119 Trade/Device Name: PROCOTYL® L-O Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO Dated: January 20, 2015 Received: January 22, 2015

Dear Mr. Ledbetter:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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

Page 2 - Mr. Byron Ledbetter

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 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.

Mark N. Melkerson -S

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142119

Device Name

PROCOTYL® L-O Acetabular System

Indications for Use (Describe)

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and.
revision procedures where other treatments or devices have failed

The PROCOTYL® L-O Acetabular System utilizes single use components. intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

Image /page/3/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with a white circle and a red diamond inside, followed by the text "MicroPort" in blue and "Orthopedics" in red. Below the logo is the text "MicroPort Orthopedics Inc." in black.

510(k) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROCOTYL® L-O Acetabular System.

Submitted by:	MicroPort Orthopedics Inc.5677 Airline RdArlington, TN 38002Phone: (866) 872-0211Fax: (855) 446-2247
Date:	February 18, 2015
Contact Person:	Byron LedbetterRegulatory Affairs Specialist II
Proprietary Name of Modified Device:	PROCOTYL ® L-O Acetabular System
Common Name:	acetabular shell, acetabular liner and femoralhead
Classification Name and Reference:	888.3358 LPHHip joint metal/polymer/metal semi-Constrained porous-coateduncemented prosthesisClass II
	888.3353 LZOHip joint metal/ceramic/polymer semiconstrained cemented or nonporous,uncemented prosthesisClass II
Subject Product Code and Panel Code:	Orthopedics/87/LPH/LZO
Predicate Devices:	LINEAGE™ Acetabular System (K002149shells; K052026 liners)
	DYNASTY® Acetabular System (K13037628mm heads; K140043 32-36mm heads)

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

Image /page/4/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red underneath. Below the logo is the text "MicroPort Orthopedics Inc." in black.

Device Description

Intended Use

The PROCOTYL® L-O Acetabular System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed

The PROCOTYL® L-O Acetabular System utilizes single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.

Technological Characteristics of the Device

The indications for use of the PROCOTYL® L-O Acetabular System are identical to those for the predicate devices for the head (K130376 and K140043) and shells/liners (K002149). The subject devices are made from an identical Titanium Alloy, Ti6Al4V, wrought or forged (ASTM F136 or ASTM F620 respectively) and possess an identical titanium plasma spray coating (ASTM F1580) or beaded coating (ASTM F1580/F67) as the predicate device.

Nonclinical Testing

The PROCOTYL® L-O Acetabular System ceramic heads were evaluated for static compression to failure and were deemed acceptable per ISO 7206-10. Additionally, the PROCOTYL® L-O Acetabular System was evaluated for range of motion and was deemed acceptable per ISO 21535.

Clinical Testing

Clinical data was not provided for the subject devices.

Conclusions

The indications for use and fundamental scientific technology of the PROCOTYL® L-O Acetabular System are identical to those of the predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The safety and effectiveness of the PROCOTYL® L-O Acetabular System are adequately supported by the substantial equivalence information, materials information, and nonclinical testing data provided within this premarket notification.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.