Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

K241491 · Stryker Corporation (Tornier, S.A.S.) · PHX · Oct 10, 2024 · Orthopedic

Device Facts

• Record ID: K241491
• Device Name: Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid
• Applicant: Stryker Corporation (Tornier, S.A.S.)
• Product Code: PHX · Orthopedic
• Decision Date: Oct 10, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BLUEPRINT™ Patient Specific Instrumentation IFU: Hardware The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed 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. Software Blueprint® is a medical device for surgeons. Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific components (patient-specific instruments and Shoulder iD™ Primary Reversed Glenoid*) based on the pre-surgical plan. Blueprint® leads to the generation of a planning report. Blueprint® 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 Shoulder iD™ Primary Reversed Glenoid are available in your geography. Shoulder iD™ Primary Reversed Glenoid IFU: The Shoulder iD™ 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 cuff-tear 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 Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

Device Story

Blueprint Patient-Specific Instrumentation and Shoulder iD Primary Reversed Glenoid system; used for preoperative planning and intraoperative guidance in shoulder arthroplasty. Input: patient CT scan images (DICOM). Software allows surgeons to visualize, measure, reconstruct, and annotate anatomy; simulate range of motion; select implants; and design patient-specific glenoid drill guides and implants. Output: planning report and patient-specific hardware. Used by orthopedic surgeons in clinical settings. Guides assist in precise intraoperative positioning of glenoid components. Implant (baseplate, screws, glenosphere) replaces native glenoid surface via non-cemented fixation. Benefits: improved surgical planning and implant positioning based on patient-specific anatomy.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by non-clinical bench testing, including dimensional analysis, cadaveric testing, and reverse glenoid loosening testing.

Technological Characteristics

System includes patient-specific drill guides and planning software. Implant: baseplate with press-fit post, peripheral screws, and glenosphere; non-cemented fixation. Software: DICOM-based preoperative planning, visualization, and measurement. Connectivity: Online Management System (OMS).

Indications for Use

Indicated for adult patients with reached bone maturity requiring shoulder joint replacement due to massive, non-repairable rotator cuff tear with pain, rheumatoid arthritis, non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), functional deformity, humeral head fractures, traumatic arthritis, or revision of glenohumeral joint with sufficient native bone. Requires functional deltoid muscle.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• BLUEPRINT™ Patient Specific Instrumentation (K232265)
• BLUEPRINT™ Patient Specific Instrumentation + Tornier Perform (K211359)

Reference Devices

• Akunah REFLECT (K222987)

Submission Summary (Full Text)

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

October 10, 2024

Stryker Corporation (Tornier, S.A.S.) Aymen Azaiez Principal Regulatory Affairs Specialist 161 rue Lavoisier Montbonnot-Saint-Martin, 38330 France

Re: K241491

Trade/Device Name: Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid 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: September 6, 2024 Received: September 6, 2024

Dear Aymen Azaiez:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Farzana Digitally signed by Farzana Sharmin -S Date: 2024.10.10 Sharmin -S 12:23:24 -04'00'

Farzana Sharmin, PhD 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

Submission Number (if known)

K241491

Device Name

Blueprint Patient-Specific Instrumentation: Shoulder iD Primary Reversed Glenoid

ndications for Use (Describe)

BLUEPRINT™ Patient Specific Instrumentation IFU:

Hardware

The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed 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.

Software

Blueprint® is a medical device for surgeons.

Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific components (patient-specific instruments and Shoulder iD™ Primary Reversed Glenoid*) based on the pre-surgical plan.

Blueprint® leads to the generation of a planning report.

Blueprint® 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 Shoulder iD™ Primary Reversed Glenoid are available in your geography.

Shoulder iD™ Primary Reversed Glenoid IFU:

The Shoulder iD™ 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 cuff-tear 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 Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.

Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

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) #: K241491 | 510(k) Summary | | | Prepared on: 2024-09-09 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------|--|-------------------------|
| Contact Details | | | | 21 CFR 807.92(a)(1) |
| Applicant Name | | Stryker Corporation (Tornier, S.A.S.) | | |
| Applicant Address | | 161 rue Lavoisier Montbonnot-Saint-Martin 38330 France | | |
| Applicant Contact Telephone | | [phone] | | |
| Applicant Contact | | Mr. Aymen Azaiez | | |
| Applicant Contact Email | | [e-mail] | | |
| Correspondent Name | | Stryker Corporation (Tornier S.A.S.) | | |
| Correspondent Address | | 161 rue Lavoisier Montbonnot-Saint-Martin 38330 France | | |
| Correspondent Contact Telephone | | [phone] | | |
| Correspondent Contact | | Mr. Aymen Azaiez | | |
| Correspondent Contact Email | | [e-mail] | | |
| Device Name | | | | 21 CFR 807.92(a)(2) |
| Device Trade Name | | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | | |
| Common Name | | Shoulder Prosthesis, Reverse Configuration | | |
| Classification Name | | Shoulder joint metal/polymer semi-constrained cemented prosthesis | | |
| Regulation Number | | 888.3660 | | |
| Product Code(s) | | PHX, KWS, QHE | | |
| Legally Marketed Predicate Devices | | | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | | | Product Code |
| K232265 | BLUEPRINT™ Pati et Specific Instrumentation | | | PHX |
| K211359 | BLUEPRINT™ Patient Specific Instrumentation + Tornier Perform | | | PHX |
| K222987 (Reference) | Akunah REFLECT | | | LLZ |
| Device Description Summary | | | | 21 CFR 807.92(a)(4) |
| BLUEPRINT™ Patient Specific Instrumentation<br>Blueprint Patient Specific Instrumentation is composed of two components: Blueprint Glenoid Guides (hardware) and Blueprint Planning Software (software) | | | | |

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### Blueprint™ Glenoid Guides

The Blueprint Glenoid Guides are patients specially designed to facilitate the implantation of Wright-Tornier glenoid prostheses.

The Blueprint Glenoid Guides are designed and manufactured based on a pre-operated only by the software Blueprint Planning Software.

Blueprint™ Planning Software

Blueprint Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer and 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.

Shoulder iD™ Primary Reversed Glenoid

The Shoulder iD Primary Reversed Glenoid implant (Shoulder iD) 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.

## Intended Use/Indications for Use

21 CFR 807.92(a)(5)

BLUEPRINT™ Patient Specific Instrumentation IFU:

Hardware

The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed 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.

Software

Blueprint® is a medical device for surgeons.

Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery.

Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format.

Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data.

Blueprint® allows surgeons to design patient-specific instruments and Shoulder iD™ Primary Reversed Glenoid*) based on the pre-surgical plan.

Blueprint® leads to the generation of a planning report.

Blueprint® 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 Shoulder iD™ Primary Reversed Glenoid are available in your geography.

Shoulder iD™ Primary Reversed Glenoid IFU:

The Shoulder iD™ Primary Reversed Glenoid in indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear 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 Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

## Indications for Use Comparison

## 21 CFR 807.92(a)(5)

For BLUEPRINT Patient Specific Instrumentations for use of the subject device are identical to the predicate device. For Shoulder iD Primary Reversed Glenoid, the indications for use of the subject device (Shoulder iD Primary Reversed Glenoid) and of the predicate device (Tornier Perform Patient-Matched Primary Reversed Glenoid) are identical except for the name of the device.

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# Technological Comparison

## 21 CFR 807.92(a)(6)

### BLUEPRINT Patient Specific Instrumentation

The subject and predicate hardware devices have identical technological features.

Technological differences between the subject and predicate software devices do not raise any different questions of safety and effectiveness and they are addressed though performance testing.

Shoulder iD Primary Reversed Glenoid.

The Shoulder iD Primary Reversed Glenoid and the predicate Tornier Perform Patient-Matched Primary Reversed Glenoid have the same technological features. The only differences between the subject and the brand name and the updated Operative Technique for the subject device. The difference in the operative technique does not raise any different questions of safety and effectiveness and is addressed though performance testing.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

### BLUEPRINT™ Patient Specific Instrumentation:

Technological differences between the subject and predicate hardware devices are supported by the dimensional the predicate device hardware which remain applicable to the subject hardware device, as 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 are supported with verification and validation evaluations. The operating principle of the subject device is the same as 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.

Shoulder iD Primary Reversed Glenoid

Non-clinical Reverse Glenoid Loosening testing was confirm substantial equivalence to the predicate device in manual bone preparation conditions.

No clinical studies were performed.

#### BLUEPRINT™ Patient Specific Instrumentation:

The subject device hardware BLUEPRINT™ Patient Specific Instrumentation does not raise any different questions of safety and effectiveness over the predicate device. Technological differences between the subject and predicate are upported by the dimensional and cadaveric tests performed on the predicate device hardware which are still applicable on the subject hardware device as the changes to the subject device do not impact functional dimensions nor material.

#### Shoulder iD Primary Reversed Glenoid

The Shoulder iD Primary Reversed Glenoid does not raise different questions of safety or effectiveness. There are in technological characteristics between the predicate and subject devices. The results of the Shoulder iD Primary Reversed Glenoid support substantial equivalence to the predicate Tornier Patient-Matched Primary Reversed Glenoid (K211359, cleared November 12, 2021).