The Conformis Hip System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the Conformis Hip System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision procedures for failed previous hip surgery (excluding situations where hardware is present).

The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.

The Conformis Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

Device Description

The Conformis Hip System is a semi-constrained, cementless artificial hip replacement system. Patient imaging (CT scans) and a combination of proprietary and off the shelf software are used to design a patient specific hip replacement system.

The Conformis Hip System consists of the following components:

a) Femoral Component:

The femoral stem, with an integrated patient specific neck, is manufactured from titanium alloy and has a plasma sprayed hydroxyapatite (HA) coating. The femoral stem is available in various sizes.
Both metal (Cobalt Chromium alloy) and Ceramic femoral heads are available for use with the Conformis Hip System. The femoral heads are available in various sizes and offsets.

b) Acetabular Component:

The acetabular cup is manufactured from titanium alloy.
The acetabular cup features a plasma sprayed outer surface. The acetabular cups are available in various sizes.
The acetabular liner is manufactured from highly cross-linked Vitamin E infused ultra-high molecular weight polyethylene (iPoly XE™). The liners are available in a range of sizes with varying internal diameters and offsets.
Acetabular screws and the apex hole plug are manufactured from titanium alloy.

c) Ancillary orthopedic manual surgical instruments
Ancillary orthopedic manual surgical instruments are provided with the Conformis Hip System to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total hip replacement components intra-operatively and in guiding the cutting/reaming of bone.

AI/ML Overview

I am sorry, but the provided FDA 510(k) clearance letter for the Conformis Hip System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as you've outlined.

This document is primarily focused on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance. It confirms that the device has similar intended use, indications for use, operating principle, materials, coatings, sterilization, and packaging as its predicate.

While it mentions "Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use," and lists specific standards (ISO-7206-4, ISO 7206-6, ASTM F2996) for "Stem and neck fatigue testing," it does not provide:

A table of acceptance criteria and reported device performance.
Sample size or data provenance for a test set.
Number of experts or their qualifications for ground truth establishment.
Adjudication method.
Information on any multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI. (This product is a physical implant, not an AI/software diagnostic device, so this is not applicable).
Information on standalone algorithm performance. (Again, not applicable).
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document states that a "Detailed software description and software verification and validation testing of proprietary software" was done, but does not provide any specifics about performance metrics or acceptance criteria for this software.

Therefore, I cannot fulfill your request based on the provided text.

Summary

FDA 510(k) Clearance Letter - Conformis Hip System

Page 1

November 6, 2019

Conformis, Inc.
Paul Smolenski
Sr. Manager Regulatory
600 Technology Park
BILLERICA MA 01821

Re: K192198
Trade/Device Name: Conformis Hip 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, MEH, OQG
Dated: August 12, 2019
Received: August 13, 2019

Dear Paul Smolenski:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Page 2

K192198 - Paul Smolenski
Page 2

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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Vesa Vuniqi
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 3

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

510(k) Number (if known): K192198

Device Name: Conformis iTotal Hip Replacement System

Indications for Use (Describe)

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision procedures for failed previous hip surgery (excluding situations where hardware is present).

The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.

The Conformis Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

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Page 4

510(K) SUMMARY (PAGE 1 OF 3)

Submitter's Name and Address:
Conformis, Inc.
600 Technology Park
Billerica, MA 01821

Establishment Registration Number: 3009844603 and 3004153240

Date of Summary: October 29, 2019

Contact Person: Paul Smolenski, Sr. Manager, Regulatory Affairs
Telephone Number: (781) 345-9093
Fax Number: (781) 345-0147

Name of the Device(s): Conformis Hip System

Common Name(s): Hip Replacement System

Regulation Number: 21 CFR 888.3358

Product Codes: LPH, LZO, MEH, OQG

Device Classification: Class II medical device

Identification of the Legally Marketed Device(s), Predicate Device(s):

Conformis iTotal Hip Replacement System (ITOTAL HRS)
Device Class: II
Product Code: LPH, LZO, MEH, OQG
Regulation Number: 21 CFR 888.3358
510(k) Number: K162719

Page 5

510(K) SUMMARY (PAGE 2 OF 3)

Device Description:

The Conformis Hip System consists of the following components:

a) Femoral Component:

The femoral stem, with an integrated patient specific neck, is manufactured from titanium alloy and has a plasma sprayed hydroxyapatite (HA) coating. The femoral stem is available in various sizes.
Both metal (Cobalt Chromium alloy) and Ceramic femoral heads are available for use with the Conformis Hip System. The femoral heads are available in various sizes and offsets.

b) Acetabular Component:

The acetabular cup is manufactured from titanium alloy.
The acetabular cup features a plasma sprayed outer surface. The acetabular cups are available in various sizes.
The acetabular liner is manufactured from highly cross-linked Vitamin E infused ultra-high molecular weight polyethylene (iPoly XE™). The liners are available in a range of sizes with varying internal diameters and offsets.
Acetabular screws and the apex hole plug are manufactured from titanium alloy.

c) Ancillary orthopedic manual surgical instruments

Ancillary orthopedic manual surgical instruments are provided with the Conformis Hip System to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total hip replacement components intra-operatively and in guiding the cutting/reaming of bone.

Indications for Use:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision procedures for failed previous hip surgery (excluding situations where hardware is present).

The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and, single use instrumentation.

Page 6

510(K) SUMMARY (PAGE 3 OF 3)

The Conformis Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following device use and characteristics:

Intended Use: Identical to the predicate device.
Indications for Use: The proposed indications for use for the Conformis Hip System are identical to the predicate device.
Operating Principle/Fundamental Technology: Identical to the predicate device. The proposed Conformis Hip System is a semi-constrained, cementless artificial hip replacement system; it consists of a femoral stem with an integrated neck and a standard femoral head, an acetabular cup with polyethylene liner, with optional acetabular screws/apex hole plugs, and ancillary instrumentation.
Materials/Coatings: The proposed Conformis Hip System uses the same biocompatible materials (i.e. titanium alloy) and coatings (i.e. hydroxyapatite) as the predicate device.
Sterilization and Packaging: Identical to the predicate device, the proposed Conformis Hip System is intended to be provided sterile (SAL 1.0x10-6) and for single use.

Substantial Equivalence:

The determination of substantial equivalence for this device was based on a detailed device description. Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use. The following non-clinical laboratory testing was performed:

Detailed software description and software verification and validation testing of proprietary software
Physical testing including Stem and neck fatigue testing was performed in compliance with the following standards:
- ISO-7206-4 (2010)
- ISO 7206-6 (2013)
- ASTM F2996 (2013)

All other performance characteristics are identical to the predicate device.

Conclusion:

Based on the testing conducted, it is concluded that the proposed Conformis Hip System is substantially equivalent to the predicate iTotal Hip Replacement System (K162719, cleared June 14, 2017).

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.