The MPACT Extension 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, hemiarthrodesis, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present

Device Description

The MPACT implants subject of this submission are comprised of the following products:

33 sizes of Offset +4mm PE liners; and
32 sizes of Face-changing +10° PE liners.

These liners are a component of a total hip joint prosthesis that is used to replace the acetabulum. The component is an inner liner made of High-Cross ultra-high molecular weight polyethylene (UHMWPE); which is inserted in the Acetabular shell.

They are all a line extension to Medacta's MPACT (K103721), and MPACT Extensions (K122641 and K132879) Systems and are designed to be used with the Medacta Total Hip Prosthesis System. In detail, the Liners subject of the current submission are compatible with the MPACT No-Hole and Two-Hole (K132879), MPACT Multi-Hole and Rim-Hole (K132879); and the Mpact 3D Metal Acetabular Shells (K171966).

As regards to the femoral head components, the MPACT Extension Liners can be combined with the CoCr Ball Heads (K072857 and K080885), MectaCer Biolox Option Heads (K131518), or with the MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

AI/ML Overview

The provided text describes the regulatory clearance for a medical device called "MPACT Extension" and details the non-clinical performance data used to demonstrate its substantial equivalence to predicate devices. It explicitly states that no clinical studies were conducted. Therefore, the acceptance criteria and study information related to human performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this submission.

Here's a breakdown of the relevant information from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Standard/Guideline	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Performance Tests
Static/Dynamic Compressive Load Testing	ASTM F1820-13	Meets requirements of ASTM F1820-13 for axial disassembly force of a modular acetabular device.	Device passed the tests, supporting substantial equivalence.
Static Lever-out Testing	ASTM F1820-13	Meets requirements of ASTM F1820-13 for axial disassembly force of a modular acetabular device.	Device passed the tests, supporting substantial equivalence.
Range of Motion	EN ISO 21535 (2007)	Meets requirements of EN ISO 21535 for hip-joint replacement implants.	Device passed the tests, supporting substantial equivalence.
Biocompatibility
Pyrogenicity (Bacterial Endotoxin Test)	European Pharmacopoeia §2.6.14 (equivalent to USP chapter <85>)	Meets requirements for bacterial endotoxin levels.	Device passed the tests.
Pyrogenicity (Pyrogen Test)	USP chapter <151>	Meets requirements for pyrogenicity determination.	Device passed the tests.

Note: The document states that testing was conducted according to written protocols with acceptance criteria based on standards. The specific numerical acceptance values or individual performance results are not explicitly listed in this summary, but the general statement "device passed the tests, supporting substantial equivalence" implies that the acceptance criteria were met for all listed non-clinical tests.

2. Sample size used for the test set and the data provenance
Not applicable. No human test set was used as this was a non-clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No human test set was used.

4. Adjudication method for the test set
Not applicable. No human test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "No clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant (hip joint component), not an algorithm or AI software for which standalone performance would be relevant.

7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" was established by the specified industry standards (ASTM F1820-13, EN ISO 21535, European Pharmacopoeia §2.6.14, USP chapter <85>, USP chapter <151>). These standards define the methodologies and acceptable performance limits for mechanical properties and biocompatibility.

8. The sample size for the training set
Not applicable. No human training set was used. "Training set" typically refers to data used to train AI models; this device is a physical implant.

9. How the ground truth for the training set was established
Not applicable. No human training set was used.

Summary

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March 21, 2019

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

Re: K183582

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 Dated: March 1, 2019 Received: March 4, 2019

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Peter G. Allen -S. The date of the signature is 2019.03.21, and the time is 20:36:00 -04'00'.

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

Enclosure

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Indications for Use

510(k) Number (if known) K183582

Device Name MPACT Extension

Indications for Use (Describe)

The MPACT Extension 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, hemiarthrodesis, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present

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)

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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 Affairs Manager, Medacta International SA

Date Prepared: Dec 20, 2018 Date Revised (1) : Jan 24, 2018 Date Revised (2) : Feb 28, 2019 Date Revised (3) : Mar 15, 2019

II. Device

Device Proprietary Name:	MPACT Extension
Common or Usual Name:	Acetabular Liners
Classification Name:	Hip joint metal/ceramic/polymer semi-constrained cementedor nonporous uncemented prosthesis
Primary Product Code:	LPH
Secondary Product Code:	LZO
Regulation Number:	21CFR 888.3358 and 21 CFR 888.3353
Device Classification	II

III. Predicate Device

For the MPACT Extension System, substantial equivalence is claimed to the following primary predicate device:

MPACT, K103721, Medacta International SA ●
Moreover, substantial equivalence is claimed to the following reference devices:
MPACT Extension, K122641, Medacta International SA ; ●
MPACT Extension, K132879, Medacta International SA ; ●
DePuy Synthes Pinnacle Altrx Acetabular liners (K072963, and K132959) ; and ●
Zimmer Biomet G7 Acetabular System (K121874).

IV. Device Description

The MPACT implants subject of this submission are comprised of the following products:

33 sizes of Offset +4mm PE liners; and
32 sizes of Face-changing +10° PE liners.

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V. Indications for Use

The MPACT Extension 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

VI. Comparison of Technological Characteristics

The Offset 4mm PE HC Liners and Face-changing 10° PE HC Liners and the reference devices DePuy Synthes Pinnacle Altrx Acetabular liners (K072963, K102423, and K132959) and the Zimmer Biomet G7 Acetabular System (K121874), share the following characteristics:

sizes ●
design
device usage;

Moreover, with the primary Medacta predicate device MPACT Liners cleared under K103721, and with the additional Medacta reference devices MPACT Extension (K122641 and K132879) they also share the following characteristics:

material of construction; ●
design/ locking mechanism ●
biocompatibility; ●
sterility; ●
shelf life; and ●
packaging.

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The fundamental scientific technology of the subject devices is substantially equivalent to the predicate devices. The safety and effectiveness of the subject devices is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

VII. Performance Data

Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed in substantial equivalence determination:

Non-Clinical Studies:

. Performance Tests
- Static/Dynamic Compressive Load Testing: ASTM F1820-13: Standard Test O Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
- Static Lever-out Testing: ASTM F1820-13: Standard Test Method for O Determining the Axial Disassembly Force of a Modular Acetabular Device
- Range of Motion: EN ISO 21535 (2007): Non-active surgical implants Joint O replacement implants - Specific requirements for hip-joint replacement implants.
Pyrogenicity (valid for all the subject devices)
- Bacterial Endotoxin Test (LAL test) was conducted according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and pyrogen test according to USP chapter <151> for pyrogenicity determination; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. O

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 performance evaluations. The MPACT Extension implants are as safe and effective as the predicate devices, MPACT extension (K103721, K122641, and K132879), DePuy Synthes Pinnacle Altrx Acetabular liners (K072963, K102423, and K132959), Zimmer Biomet G7 Acetabular System (K121874).

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.