· 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 Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or surgical technique.

Device Description

The Actera™ hip system is an uncemented, total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. X-ray templates, acetate or digital, are provided for determining implant sizes and component placement. Non-sterile reusable instruments are provided. The subject Actera™ hip system is comprised of the subject Actera™ femoral stem and the previously cleared compatible femoral head, Cordera acetabular cup, Cordera cup liner and Cordera screws (predicate K202484).

The subject, Actera™ femoral stem, is a re-designed stem. The stem is a proximally filling, triple-tapered design that is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581).

The femoral stem has an integrated neck with neck angle of 132° and neck length that progressively increases with stem size. Each size has two neck options: a standard neck, and a high offset neck that is shifted medially to provide additional femoral offset with the same leg length. The trunnion is a Conformis standard 12/14 taper, possessing a 12.7 mm diameter along with 5° 42′ 30″ angle with an asmachined geometry to form a taper lock with a mating femoral head implant. The trunnion is identical to that of the predicate Conformis Cordera femoral stem. The trunnion is designed to mate with existing standard 12/14 femoral heads. The stem body has a smooth tapered geometry in three planes. The proximal neck surface of the stem is highly polished; its geometry is intended to maximize range of motion. The femoral stems are designed to maximize contact between the stem and cancellous bone of the intramedullary canal and utilize press-fit fixation. The stem body is fully coated with hydroxyatite (HA) coating in conformance to ASTM F1185 on top of a proximal coating of commercially pure titanium (CPTi) conforming to ASTM F1580.

The femoral heads are unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (BIOLOX® delta). The femoral heads are designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem.

The acetabular component is unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). It consists of a standard size shell in 1mm increments with standard screw hole placement, a mating vitamin E polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fit through the acetabular shell screw holes and are driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation.

The purpose of this submission is to seek clearance of the subject Actera™ femoral stem which is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581). The subject Actera femoral stem is compatible with the previously cleared femoral head, Cordera acetabular cup and liner, Cordera screws and reusable instruments (class I) as described in the predicate K210581. . This submission also seeks clearance for new class II reusable instruments. New class I 510Kexempt reusable instruments and x-ray templates are also described.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a hip replacement system (Actera™ hip system). This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials as seen with PMAs or de novo devices.

Therefore, the information you're asking for, such as acceptance criteria based on metrics like sensitivity, specificity, or ROC AUC, sample sizes for test/training sets for AI, expert numbers for ground truth, MRMC studies, or standalone algorithm performance, is not applicable to this type of device submission and its accompanying documentation.

The document primarily focuses on:

Device Description: What the device is and its components.
Indications for Use: What conditions the device is intended to treat.
Technological Characteristics Comparison: How the new device (specifically the Actera™ femoral stem) is similar to a predicate device in terms of materials, design principles, manufacturing, etc.
Non-Clinical Performance Evaluation: This section details bench testing (in vitro/mechanical testing) performed on the device to ensure it meets established standards and performs comparably to the predicate. This is crucial for demonstrating substantial equivalence for orthopedic implants.

Here's a breakdown of the provided information in relation to your request, highlighting what's present and what's absent (due to the nature of a 510(k) for an orthopedic implant):

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

For this type of orthopedic implant, acceptance criteria are typically defined by engineering and mechanical performance standards, not statistical metrics for AI performance. The document lists the types of tests performed:

Test Type	Standard/Method	Reported Performance/Conclusion
Proximal Stem Fatigue Testing	ISO 7206-6	Results support device is safe, effective, and performs as well as predicate
Distal Stem Fatigue Testing	ISO 7206-4	Results support device is safe, effective, and performs as well as predicate
Range of Motion Analysis	ISO 21535	Results support device is safe, effective, and performs as well as predicate
Impingement Analysis	Not specified (implied by ISO 21535)	Results support device is safe, effective, and performs as well as predicate
Coating Characterization Testing	ASTM F1854	Results support device is safe, effective, and performs as well as predicate
(Stereological Porous Coating Evaluation)	ASTM F1147
(Static Tensile Testing)	ASTM F1044
(Static Shear Testing)	ASTM F1160
(Shear and Bending Fatigue Testing)	ASTM F1978
(Taber Abrasion Testing)	ASTM F1926
(Dissolution Rate Testing)	ASTM F2024
(Phase Composition Testing - X-ray	Not specified (XRD, wet chemistry)
Diffraction)
Ca/P Ratio Characterization Testing
Endotoxin Levels (Biocompatibility/Sterility)	Limulus Amebocyte Lysate (LAL) using gel-clot method	Within recommended levels of 0.5 EU/mL or 20 EU/device

Note: The document states, "The results of the testing support that the subject device is safe, effective and performs as well as or better than the predicate device. No new issues of safety or efficacy were raised." Specific numerical performance data (e.g., fatigue strength in MPa) are typically found in the full 510(k) submission, but usually not summarized in the publicly available summary letter.

2. Sample sizes used for the test set and the data provenance

Sample Size: Not applicable. For mechanical testing, "samples" refer to physical test specimens (e.g., a certain number of stems subjected to fatigue testing), not patient data for an AI algorithm. The document does not specify the number of physical specimens tested for each type of bench test.
Data Provenance: Not applicable. This is not a study involving patient data (retrospective or prospective) from specific countries, but rather laboratory bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable: This device does not involve AI or image analysis where human expert ground truth is established. The "ground truth" for mechanical testing is adherence to international standards (ISO, ASTM) and predefined engineering specifications.

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

Not applicable: No human adjudication is involved for bench testing of an orthopedic implant.

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 is an orthopedic implant, not an AI-powered diagnostic device.

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

Not applicable: This is an orthopedic implant, not an AI algorithm.

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

Not applicable: The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ISO, ASTM).

8. The sample size for the training set

Not applicable: This is an orthopedic implant, not an AI device that requires training data.

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

Not applicable: This is an orthopedic implant, not an AI device.

In summary, the provided document aligns with the typical process for 510(k) clearance of a Class II orthopedic implant. The "study" that proves the device meets acceptance criteria is a series of non-clinical (bench) tests designed to demonstrate that the device performs equivalently to the predicate and meets relevant industry standards for mechanical properties and biocompatibility.

Summary

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August 4, 2022

Conformis Inc. Mary Kruitwagen Sr. Regulatory Affairs Specialist 600 Technology Park Drive, 4th Floor Billerica, Massachusetts 01821

Re: K221104

Trade/Device Name: Actera™ hip system Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH, OOG Dated: May 24, 2022 Received: May 25, 2022

Dear Mary Kruitwagen:

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.

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

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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 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-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Limin Sun, Ph.D. 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

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Indications for Use

510(k) Number (if known) K221104

Device Name Actera™ hip system

Indications for Use (Describe)

Total hip replacement using the Actera™ 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, theumatoid 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 Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or surgical technique.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Submitter's Name and Address:	Conformis, Inc.600 Technology Park Drive,Fourth FloorBillerica, MA 01821USA
Establishment RegistrationNumber(s):	3009844603 and 3004153240
Date Summary was Prepared:	July 19, 2022
Contact Person:	Mary KruitwagenSr. Regulatory Affairs Specialist
Contact Information:	Mary.Kruitwagen@conformis.com781-345-9038
Trade/Device Name(s)	Actera™ hip system
Common Name:	Total Hip Replacement System
Device Class:	Class 2
Regulation Number(s) andClassification Names	21 CFR 888.3353, Hip Joint Metal/Ceramic/Polymer Semi-ConstrainedCemented Or Nonporous Uncemented Prosthesis21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis
Product Codes:	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate (MEH)Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, +Additive, Porous, Uncemented (OQG)
Primary Predicate Device:	K210581 DePuy Orthopaedic Inc. ACTIS® Duofix Hip Prothesis
Reference Device:	K202484 Conformis Cordera Hip System

Device Description:

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stem and the previously cleared compatible femoral head, Cordera acetabular cup, Cordera cup liner and Cordera screws (predicate K202484).

Indications for Use:

Total hip replacement using the Actera™ 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, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.

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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 Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or posterior surgical technique.

Indications and Technological Characteristics Comparison:

The indications for use in total hip replacement are similar to the primary predicate. The subject indications for use differ from the primary predicate because the subject system is not indicated for use in hemi-hip replacement. However, the subject device indications for use are almost identical to the reference device total hip replacement system and only differ through modification to include the lateral approach. The subject device incorporates total hip arthroplasty components with materials and designs that are the similar to the DePuy Orthopaedics ACTIS® DuoFix Hip Prothesis, K210581 predicate. The operating principle, fundamental technology, materials, manufacturing methods and sterilization options are the same as the predicate.

Non-Clinical Performance Evaluation:

Performance testing includes proximal stem fatigue testing (ISO 7206-6), distal stem fatigue testing (ISO 7206-4), range of motion analysis per ISO 21535, impingement analysis, and coating characterization testing (ASTM F1854 stereological porous coating evaluation, ASTM F1147 static tensile testing, ASTM F1044 static shear testing, ASTM F1160 shear and bending fatigue testing, ASTM F1978 Taber abrasion testing, ASTM F1926 dissolution rate testing, ASTM F2024 phase composition testing per X-ray diffraction, and Ca/P ratio characterization testing using XRD analysis or wet chemistry method). Limulus Amebocyte Lysate (LAL) testing using the gel-clot method is employed to monitor the endotoxin levels of the subject and predicate implanted device and ensures they are within the recommended levels of 0.5 EU/mL or 20 EU/device. Verification and validation studies were also conducted. The results of the testing support that the subject device is safe, effective and performs as well as or better than the predicate device. No new issues of safety or efficacy were raised.

Conclusion:

Based on a comparison of the intended use and technological characteristics of the subject device to predicate, and the results of the confirmatory testing, it is concluded that the proposed Actera™ hip system is considered substantially equivalent.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.