Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator with pain disabled by: Rheumatoid arthritis, Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), Correction of functional deformity, Fractures of the humeral head, Traumatic arthritis, Revision of glenohumeral joint if sufficient native glenoid bone remains. All components are single use. The Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant.

BLUEPRINT™ Patient Specific Instrumentation:
BLUEPRINT ™ Glenoid Guides: The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgerv. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose. Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if Patient-Specific instruments or Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.

Device Description

Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant (Patient-Matched Glenoid) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis. The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

BLUEPRINT™ Patient Specific Instrumentation: BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and BLUEPRINT™ 3D Planning Software is the responsibility of Tornier is the legal manufacturer for the hardware and the software.
BLUEPRINT ™ Glenoid Guides: The BLUEPRINT ™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Generate information required to design a patient-specific glenoid component when appropriate.

AI/ML Overview

This document, K211359, is a 510(k) premarket notification for the Tornier Perform™ Patient-Matched Primary Reversed Glenoid (implant) and BLUEPRINT™ Patient Specific Instrumentation (hardware and software). The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through clinical trials. As such, the information provided focuses on non-clinical performance and verification/validation, largely relying on the predicate device's established safety and effectiveness.

Therefore, the following information, which typically applies to AI/software as a medical device (SaMD) clearances involving complex algorithms and clinical performance studies, is largely not present in this 510(k) summary. The provided text explicitly states that "No clinical studies were performed." This indicates that the device's performance was not evaluated through a study comparing it to an established ground truth in the way a traditional AI/SaMD clinical study would.

Here is a breakdown based on the provided document and the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing for both the implant and the instrumentation. These are engineering/material specifications rather than clinical performance metrics for an AI algorithm.

Component / Test Area	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Tornier Perform™ Patient-Matched Primary Reversed Glenoid (Implant)	(Demonstrate substantial equivalence to predicate)	Supported by performance testing
Baseplate Pullout	(Adequate mechanical strength)	Performed, results led to substantial equivalence
Fatigue	(Resistance to cyclic loading)	Performed, results led to substantial equivalence
Reverse Glenoid Loosening	(Stability of the implant)	Performed, results led to substantial equivalence
Range of Motion	(Functional movement with implant)	Performed, results led to substantial equivalence
MRI compatibility evaluation	(Compatibility with MRI)	Performed, results led to substantial equivalence
Porous Structure	(Material properties)	Performed, results led to substantial equivalence
Biocompatibility, sterilization, cleaning, endotoxin, particulate, packaging, shelf life, and distribution	(Meet recognized consensus standards)	Assessed in accordance with recognized consensus standards
BLUEPRINT™ Patient Specific Instrumentation (Hardware)	(Demonstrate substantial equivalence to predicate; non-functional dimensional changes)	Supported by dimensional tests on predicate (remain applicable) and cadaveric tests on subject device.
BLUEPRINT™ 3D Planning Software (Software)	(Demonstrate substantial equivalence to predicate; no new questions of safety/effectiveness)	Supported with verification and validation evaluations. Operating principle is the same as predicate. Differences in design do not raise new safety/effectiveness questions.

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

Test Set Sample Size: Not applicable in the context of a clinical performance test for an AI algorithm. The tests described are non-clinical engineering/materials tests (e.g., pullout, fatigue). For the software, "verification and validation evaluations" were performed, but no specific number of cases or data provenance is detailed, as it's a conformity assessment to the predicate's operating principle.
Data Provenance: Not applicable for an AI algorithm evaluation in this context. The document mentions "cadaveric test performed on the subject device" for the hardware, which would be test data, but not a "test set" in the sense of clinical images for an AI.

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

Not applicable as no clinical study or AI algorithm evaluation with human expert ground truth was performed.

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

Not applicable as no clinical study or AI algorithm evaluation with adjudicated ground truth was performed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." Therefore, there is no effect size on human reader improvement with AI assistance.

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

For the BLUEPRINT™ 3D Planning Software, "verification and validation evaluations" were performed. While these evaluations assess the algorithm's functionality, they are not presented as a standalone performance study in a clinical context (e.g., measuring diagnostic accuracy against a ground truth dataset). The software is a planning tool, not a diagnostic AI.

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

For the non-clinical tests (implant): Engineering specifications, material properties, and established consensus standards serve as the "ground truth" for the physical device's performance.
For the software: The ground truth would be the accuracy and correctness of the planning outputs and measurements generated by the software, compared to expected or designed values. This is typically assessed through software verification and validation against a golden standard or internal reference data, not clinical ground truth like pathology or outcomes.

8. The sample size for the training set:

Not applicable, as this is a 510(k) for an orthopedic implant and a planning software, not a deep learning AI model that requires a "training set" in the same sense. The software's design and programming are based on established anatomical and biomechanical principles.

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

Not applicable, as no external "training set" with established ground truth, typical for AI model development, is mentioned.

Summary

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November 12, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Tornier, Inc. Lisa Stahl Principal Specialist, Regulatory Affairs 10801 Nesbitt Ave South Bloomington, Minnesota 55437

Re: K211359

Trade/Device Name: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, QHE Dated: October 8, 2021 Received: October 12, 2021

Dear Lisa Stahl:

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 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

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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,

For Jiping Chen, PhD Acting Division 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) K211359

Device Name

Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

Indications for Use (Describe)

Tornier Perform™ Patient-Matched Primary Reversed Glenoid

The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator with pain disabled by:

· Rheumatoid arthritis
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of glenohumeral joint if sufficient native glenoid bone remains

All components are single use.

The Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant.

BLUEPRINT™ Patient Specific Instrumentation

BLUEPRINT ™ Glenoid Guides

The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

BLUEPRINT™ 3D Planning Software

BLUEPRINT™ 3D Planning Software is a medical device for surgeons.

BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgerv. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format.

BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report.

BLUEPRINT™ 3D Planning Software is to be used for adult men and women patients only whose bone maturity is

reached and should not be used for diagnostic purpose.

Note: Measures and patient specific guide design are provided depending on the case profiles.

*Only if Patient-Specific instruments or Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.

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.

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Image /page/4/Picture/0 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a hexagonal shape, also in blue, containing a stylized letter "T" within it. The logo appears to be a corporate logo or brand identity.

Date Prepared: October 8, 2021

Administrative Information

	Tornier Perform Patient-Matched Primary Reversed Glenoid (Implant)
Name:	Tornier, Inc.
Address:	10801 Nesbitt Avenue South
	Bloomington, MN 55437
	United States of America

BLUEPRINT Patient Specific Instrumentation

Name:	Tornier SAS
Address:	161 rue Lavoisier38330 Montbonnot Saint Martin-France
Contact Person:	Lisa Stahl
Title:	Principal Specialist, Regulatory Affairs
Phone (mobile):	612-849-9970
Fax:	952-426-7601

Device Information

Tornier, Inc.

Name of Device:	Tornier Perform™ Patient-Matched Primary Reversed Glenoid
Common Name (s):	Shoulder Prosthesis
Regulatory Class:	II
Regulation:	21 CFR 888.3660
Product Codes:	PHX, KWS

Tornier SAS

Name of Device:	BLUEPRINT™ Patient Specific Instrumentation
Common Name (s):	Patient Specific Instrumentation + 3D Planning Software
Regulatory Class:	II
Regulation:	21 CFR 888.3660
Product Codes:	KWS, QHE

Predicate Device Information

Tornier, Inc.
Primary Predicate:	AEQUALIS™ PERFORM Reversed Glenoid, K161742
Reference Device:	ZIMMER BIOMET Comprehensive Vault Reconstruction System, K152754Exactech Equinoxe, K110708
Tornier SAS

Primary Predicate:	BLUEPRINT™ Patient Specific Instrumentation, K20331.
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Image /page/5/Picture/1 description: The image shows the word "TORNIER" in a large, bold, blue font. To the right of the word is a blue hexagon with a stylized "T" inside. The "T" is also blue and has a smaller hexagon inside of it.

Device Description

Tornier Perform™ Patient-Matched Primary Reversed Glenoid

The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant (Patient-Matched Glenoid) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.

The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

BLUEPRINT™ Patient Specific Instrumentation

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).

BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and BLUEPRINT™ 3D Planning Software is the responsibility of Tornier is the legal manufacturer for the hardware and the software.

BLUEPRINT ™ Glenoid Guides

The BLUEPRINT ™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses.

The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software.

BLUEPRINT™ 3D Planning Software

BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed).

It is intended to help to plan an operation by allowing surgeons to:

. Plan for shoulder arthroplasty cases
. Position and select glenoid and humeral implants,
Simulate the prosthetic range of motion,
Interact with implants and different computed measurements
. Generate information required to design a patient-specific glenoid component when appropriate.

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Image /page/6/Picture/1 description: The image shows the logo for Tornier. The word "TORNIER" is written in large, blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of another stylized letter "T".

Intended Use

Tornier Perform™ Patient-Matched Primary Reversed Glenoid

The implant is intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.

BLUEPRINT™ Patient Specific Instrumentation

BLUEPRINT ™ Glenoid Guides

BLUEPRINT™ 3D Planning Software

BLUEPRINT™ 3D Planning Software is an application that helps a surgeon plan their patients' shoulder prosthesis surgery. When possible, it generates the information required to produce patient specific components.

Indications for Use

Tornier Perform™ Patient-Matched Primary Reversed Glenoid

Rheumatoid arthritis ●
. Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
Correction of functional deformity .
Fractures of the humeral head ●
Traumatic arthritis ●
. Revision of glenohumeral joint if sufficient native glenoid bone remains

All components are single use.

The Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.

Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant.

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Image /page/7/Picture/0 description: The image shows the word "TORNIER" in a large, blue, serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of a smaller hexagon. The logo appears to be for a company or organization called "Tornier".

BLUEPRINT™ Patient Specific Instrumentation

BLUEPRINT ™ Glenoid Guides

BLUEPRINT™ 3D Planning Software

BLUEPRINT™ 3D Planning Software is a medical device for surgeons.

BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgery.

BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format.

BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data.

BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan.

BLUEPRINT™ 3D Planning Software leads to the generation of a planning report.

BLUEPRINT™ 3D Planning Software is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

Note: Measures and patient specific guide design are provided depending on the case profiles.

*Only if Patient-Specific instruments or Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.

Comparison to Predicate Device

Tornier Perform™ Patient-Matched Primary Reversed Glenoid

The TORNIER PERFORM™ Patient-Matched Primary Reversed Glenoid and the predicate AEQUALISTM PERFORM Reversed Glenoid have the same intended use, same principle of operation, and similar technological features. The subject device patient-specific augmentation.

BLUEPRINT™ Patient Specific Instrumentation

The subject device BLUEPRINT™ Patient Specific Instrumentation and the predicate device BLUEPRINT™ Patient Specific Instrumentation (K203315) have the same intended use, similar principal of operation and similar general technological features.

Differences for subject BLUEPRINTTM Patient Specific Instrumentation include:

. For the hardware: New guides dedicated to Tornier Perform™ Patient-Matched Primary Reversed Glenoid with nonfunctional dimensions changes, delivered sterile.
For the software, planning for Tornier Perform™ Patient-Matched Primary Reversed Glenoid ● additional measurement and screw planning.

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Image /page/8/Picture/1 description: The image shows the word "TORNIER" in large, blue, sans-serif font, followed by a blue hexagon containing a stylized letter "T" with a smaller hexagon inside it. The word "TORNIER" is the main focus, with the hexagon and "T" symbol serving as a logo or emblem. The overall design is clean and professional, suggesting a corporate or institutional identity.

Non-clinical Performance Testing

Tornier Perform™ Patient-Matched Primary Reversed Glenoid

Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device.

Baseplate Pullout ●
. Fatigue
. Reverse Glenoid Loosening
Range of Motion
MRI compatibility evaluation .
. Porous Structure

Biocompatibility, sterilization, cleaning, endotoxin, particulate, packaging, shelf life, and distribution for the Tornier Perform "M Patient-Matched Primary Reversed Glenoid components were also assessed in accordance with recognized consensus standards.

BLUEPRINT™ Patient Specific Instrumentation

Technological differences between the subject and predicate hardware devices are supported by the dimensional test performed on the predicate device hardware which remain applicable to the subject hardware device, as the changes to the subject device do not impact functional dimensions or material, and cadaveric test performed on the subject device.

Technological differences between the subject and predicate software devices are supported with verification and validation evaluations. The operating principle of the subject device is that of the predicate device.

The differences in design specifications do not raise new questions of safety and effectiveness over the predicate device as demonstrated in validation testing.

Clinical Testing

No clinical studies were performed.

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Image /page/9/Picture/1 description: The image shows the word "TORNIER" in large, blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized letter "T". The letter "T" is also blue and is made up of two smaller hexagons.

Conclusions

Tornier Perform™ Patient-Matched Primary Reversed Glenoid

The Tornier Perform™ Patient-Matched Primary Reversed Glenoid does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with performance testing. The results of performance testing for the Tornier Perform™ Patient-Matched Primary Reversed Glenoid support substantial equivalence to the primary predicate AEQUALIS™ PERFORM™ Reversed Glenoid (K161742, cleared November 15, 2016).

BLUEPRINT™ Patient Specific Instrumentation

The BLUEPRINT™ Patient Specific Instrumentation does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with verification and validation testing. The results support substantial equivalence to the predicate BLUEPRINT™ Patient Specific Instrumentation (K203315, cleared April 15, 2021).

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”