· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.

· Avascular necrosis of the femoral head.
· Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Mpact 3D Metal Implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis

• Avascular necrosis of the femoral head

· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries.

The Augments 3D Metal are indicated in cases of:

Congenital dysplasia.
· Acetabular fractures.

· Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.

The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis or
psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis
Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplastv, or total hip replacement where sufficient bone stock is present.

Device Description

The MPACT Extension implants subject of this submission are twelve (12) sizes of Cancellous Bone Screws.

The subject devices are sterile implantable devices intended to be used during Total Hip Arthroplasty.

Analogously to the predicate Cancellous Bone Screws flat head (K103721 and K132879), the subject Cancellous Bone Screws, are made of titanium alloy (Ti6-A14-V) according to ISO 5832-3:2016 Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4vanadium allov. As the predicate devices, they have been designed with a thread diameter of 6.5 mm to provide fixation of implants to the cancellous bone. They can be coupled with implants that have dedicated fixation holes with a spherical seat shape of Ø8mm.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called "MPACT Extension," which consists of Cancellous Bone Screws for total hip arthroplasty.

Based on the provided text, a conventional "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD) study (as implied by the detailed breakdown requested in the prompt) were not performed. The document describes the acceptance criteria and study for a physical implantable medical device, specifically cancellous bone screws, not a software or AI product.

Therefore, many of the requested points, such as AI-specific acceptance criteria, multi-reader multi-case studies, ground truth establishment for training sets, etc., are not applicable to this document.

However, I can extract the relevant information provided for the device described:

1. A table of acceptance criteria and the reported device performance (for the hardware device):

The document does not explicitly present a table of numerical "acceptance criteria" for the performance of the cancellous bone screws in the way one might for a software or AI algorithm (e.g., target accuracy, sensitivity). Instead, acceptance is based on demonstrating substantial equivalence to predicate devices through various tests and material properties. The performance is assessed through meeting standards and showing compatibility.

Category	Acceptance Criteria (Implied by Regulatory Standards)	Reported Device Performance
Material	Made of titanium alloy (Ti6-A14-V) conforming to ISO 5832-3:2016.	"Made of titanium alloy (Ti6-A14-V) according to ISO 5832-3:2016 Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4vanadium alloy."
Fixation Capability	Designed for fixation of implants to the cancellous bone.	"Designed with a thread diameter of 6.5 mm to provide fixation of implants to the cancellous bone."
Compatibility	Compatible with implants having dedicated fixation holes with a spherical seat shape of Ø8mm.	"They can be coupled with implants that have dedicated fixation holes with a spherical seat shape of Ø8mm."
Sterility & Safety	Must be sterile, biocompatible, and non-pyrogenic. Shelf-life established.	BIOCOMPATIBILITY evaluation: according to ISO 10993. SHELF-LIFE testing: according to ISO 11607-1 and ISO 11607-2. PYROGENICITY: Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter <85>). Pyrogen test according to USP chapter <151>. Sterility: "The subject devices are sterile implantable devices." Biocompatibility, sterility, and shelf life are listed as shared characteristics with predicate devices.
Design Validation	Design must be validated for functionality and compatibility.	DESIGN VALIDATION: "Cancellous Bone Screw Ø6.5 design Validation rationale A1 item 3" and "Cancellous Bone Screw Ø6.5 acetabular shell compatibility Validation rationale A2 item 3."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in the document in terms of traditional "test sets" for a software algorithm. The "test set" for this physical device would refer to the number of screws tested during design validation, biocompatibility, and sterility testing. This number is not provided.
Data Provenance: Not applicable in the context of a software data set (e.g., country of origin, retrospective/prospective). The document describes non-clinical studies performed on the device itself.

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

Not applicable. This pertains to a physical medical device, not a software/AI product requiring expert ground truth for image interpretation or similar. The "ground truth" for this device would be its physical and chemical properties and mechanical performance as evaluated through standard laboratory testing.

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

Not applicable. This is a method for reconciling differences in expert annotations for AI/software ground truth.

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:

No, an MRMC comparative effectiveness study was not done. The device is a physical implant, not an AI or diagnostic software tool.
Effect size: Not applicable.

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

Not applicable. This refers to AI algorithm performance.

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

For this physical device, the "ground truth" is established through objective laboratory testing against recognized standards (e.g., ISO for materials, biocompatibility tests, pyrogenicity tests). It's about demonstrating the device's physical properties and safety characteristics meet established benchmarks, rather than interpretation of data by experts.

8. The sample size for the training set:

Not applicable. This refers to an AI training set.

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

Not applicable. This refers to an AI training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The acceptance of the MPACT Extension device (Cancellous Bone Screws) is based on demonstrating its substantial equivalence to established predicate devices (Medacta International SA, MPACT, K103721 and MPACT Extension, K132879). This substantial equivalence is supported by a series of non-clinical studies:

Design Validation: Specific rationales were provided for the design validation of the Ø6.5 Cancellous Bone Screw and its compatibility with acetabular shells. This ensures the device's design is adequate for its intended use.
Biocompatibility Evaluation: Performed according to ISO 10993, demonstrating the device is suitable for implantation without adverse biological reactions.
Shelf-Life Testing: Conducted according to ISO 11607-1 and ISO 11607-2, ensuring the device maintains its properties and sterility over its intended shelf life.
Pyrogenicity Testing: Bacterial Endotoxin Test (LAL test) per European Pharmacopoeia §2.6.14 (equivalent to USP chapter <85>) and Pyrogen test per USP chapter <151> were performed to ensure the device is not pyrogenic.

No clinical studies were conducted for this 510(k) submission, as stated under "Clinical Studies" in Section VII. The substantial equivalence was determined based on the comparison of intended use, design, technological characteristics, and the non-clinical design validations.

Summary

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

April 28, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle. The FDA acronym is in a blue square, and the full name of the agency is in blue text.

Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K200391

Trade/Device Name: MPACT Extension 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 Dated: March 31, 2021 Received: April 1, 2021

Dear Chris Lussier:

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 mav, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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

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 (OS) 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,

Vesa 2021.04.28
16:46:25
Vuniqi -S -04'00'

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

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

Indications for Use

510(k) Number (if known) K200391

Device Name MPACT Extension

Indications for Use (Describe)

The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.

· Avascular necrosis of the femoral head.
· Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Mpact 3D Metal Implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis

• Avascular necrosis of the femoral head

· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries.

The Augments 3D Metal are indicated in cases of:

Congenital dysplasia.
· Acetabular fractures.

· Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.

The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis or
psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis
Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplastv, or total hip replacement where sufficient bone stock is present.

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)

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

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:

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."

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

510(k) Summary

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: February 14, 2020 Date Revised: April 23, 2021

II. Device

Device Proprietary Name:	MPACT Extension
Common or Usual Name:	Cancellous Bone Screws
Classification Name:	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Primary Product Code:	LPH
Secondary Product code	LZO, MEH
Regulation Number:	21 CFR 888.3358 and 21 CFR 888.3353
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device

. Medacta International SA, MPACT, K103721
Additional predicate device
Medacta International SA, MPACT Extension, K132879 .

IV. Device Description

The MPACT Extension implants subject of this submission are twelve (12) sizes of Cancellous Bone Screws.

The subject devices are sterile implantable devices intended to be used during Total Hip Arthroplasty.

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

V. Indications for Use

The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, . rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
Avascular necrosis of the femoral head. .
. Acute traumatic fracture of the femoral head or neck.
. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Mpact 3D Metal Implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

. Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis
Avascular necrosis of the femoral head .
Acute traumatic fracture of the femoral head or neck .
Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multihole acetabular cup in hip replacement surgeries.

The Augments 3D Metal are indicated in cases of:

. Congenital dysplasia.
Acetabular fractures. .
. Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.

The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of:

Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, . rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis
Avascular necrosis of the femoral head .
Acute traumatic fracture of the femoral head or neck ●

{6}------------------------------------------------

Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

Comparison of Technological Characteristics VI.

The subject Cancellous Bone Screws and the predicate MPACT cancellous bone screws flat head (K103721 and K132879) share the following characteristics:

. sizes;
thread diameter .
. head shape
. material;
biocompatibility;
. device usage;
sterility;
shelf life; and .
packaging. .

The subject Cancellous Bone Screws differ from the predicate devices with respect to:

neck diameter .
. head height
screw tip shape. .

{7}------------------------------------------------

VII. Performance Data

Testing was conducted according to written protocols. The following studies were performed in support of a substantial equivalence determination:

Non-Clinical Studies:

. DESIGN VALIDATION
- 0 Cancellous Bone Screw Ø6.5 design Validation rationale A1 item 3
- o Cancellous Bone Screw Ø6.5 acetabular shell compatibility Validation rationale A2 item 3
. BIOCOMPATIBILITY evaluation according to ISO 10993
SHELF-LIFE testing according to ISO 11607-1 and ISO 11607-2 .
. PYROGENICITY
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>)
- Pyrogen test according to USP chapter <151> for pyrogenicity determination that the O subject devices are not labeled as non-pyrogenic or pyrogen free

Clinical Studies

No clinical studies were conducted ●

VIII. Conclusion

Based on the above information, the MPACT Extension implants are substantially equivalent to the identified predicate devices.

Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as design validations.

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.