BLUEPRINT™ Patient Specific Instrumentation

K203315 · Tornier S.A.S. · KWS · Apr 15, 2021 · Orthopedic

Device Facts

• Record ID: K203315
• Device Name: BLUEPRINT™ Patient Specific Instrumentation
• Applicant: Tornier S.A.S.
• Product Code: KWS · Orthopedic
• Decision Date: Apr 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Hardware 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 patientspecific preoperative CT scans. Software The BLUEPRINT™ 3D Planning Software is intended to be used as a medical software to assist in pre-operative surgical planning for shoulder surgery.

Device Story

System comprises patient-specific glenoid drill guides and 3D planning software. Software inputs: patient CT scans (DICOM format). Surgeon uses software to visualize, measure, reconstruct, and annotate shoulder anatomy; select/position implants; simulate range of motion; and design patient-specific guides. Output: planning report and custom drill guides. Guides used intraoperatively by surgeons to assist in positioning glenoid components for shoulder arthroplasty. System facilitates pre-surgical planning and intraoperative accuracy; benefits include improved implant placement based on patient-specific anatomy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including dimensional and cadaveric evaluations, and software verification and validation.

Technological Characteristics

Hardware: Titanium (Ti6Al4V) per ISO 5832-3. Software: 3D planning application connected to Online Management System (OMS). Connectivity: DICOM input. Software includes manual and automated processing modules for anatomical measurement and guide design.

Indications for Use

Indicated for adult men and women with reached bone maturity undergoing total anatomic or reversed shoulder arthroplasty. Not for diagnostic use.

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 (K162800)

Reference Devices

• PROPHECY INVISION Pre-operative Navigation System (K170968)

Submission Summary (Full Text)

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Tornier SAS Aymen Azaiez Principal Regulatory Affairs Specialist 161 rue Lavoisier Montbonnot Saint Martin, 38330 France

April 15, 2021

Re: K203315

Trade/Device Name: BLUEPRINTTM 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: KWS Dated: March 16, 2021 Received: March 17, 2021

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 (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

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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 (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@;tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2021.04.15

For Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203315

Device Name BLUEPRINTTM Patient Specific Instrumentation

Indications for Use (Describe) 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™ 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 orthopedic 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 guides 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 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the word "TORNIER" in a large, blue, sans-serif font. To the right of the word is a blue hexagon with a stylized "T" inside. The "T" is also blue and is made up of several lines that create a three-dimensional effect.

# Traditional 510(k) Premarket - BLUEPRINTTM Patient Specific Instrumentation

# Device name

BLUEPRINTTM Patient Specific Instrumentation Trade name: Common name: Patient Specific Instrumentation + 3D Planning Software Classification name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulation number: (§888.3660)

### Submitter

| Name: | TORNIER SAS |
|----------------------|------------------------------------------------------------|
| Address: | 161 rue Lavoisier<br>38330 Montbonnot Saint Martin- France |
| Registration Number: | 3000931034 |

### Company contact

| Company Name: | TORNIER SAS | | |
|-----------------|-----------------------------------------|--|--|
| Contact Person: | Mr Aymen AZAIEZ | | |
| Title: | Principal Regulatory Affairs Specialist | | |
| Address: | 161 rue Lavoisier | | |
| | 38334 Montbonnot, France | | |
| Tel: | 00 33 6 48 38 10 36 | | |
| Fax: | 00 33 4 76 61 35 59 | | |
| Email: | [e-mail] | | |

# Classification

Device class: Class II Classification panel: Orthopedic Product code: KWS

## Equivalent / Predicate device

| Trade name | 510(k) Number | Decision date | Applicant |
|----------------------------------------------------------------------|---------------|-----------------|------------------------------------|
| BLUEPRINT™ Patient Specific<br>Instrumentation (PRIMARY) | K162800 | June 10, 2016 | TORNIER SAS |
| PROPHECY INVISION Pre-<br>operative Navigation System<br>(Reference) | K170968 | August 16, 2017 | Wright Medical<br>Technology, Inc. |

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Image /page/4/Picture/0 description: The image shows the logo for Tornier, a medical device company. The logo consists of the word "TORNIER" in large, blue, serif font, followed by a stylized symbol. The symbol is a blue hexagon with a "T" inside, also in blue. The logo is clean and professional, reflecting the company's focus on medical technology.

# Device description

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. Tornier is the legal manufacturer for the hardware and the software.

## Hardware

The BLUEPRINT IM Glenoid Guides are patient-specific instruments 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.

## 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
- i Position and select glenoid and humeral implants,
- -Simulate the prosthetic range of motion,
- Interact with implants and different computed measurements i
- Design a patient specific guide for the glenoid component when appropriate.

# Materials

The commercially available BLUEPRINT™ Glenoid Guides are manufactured from titanium (Ti6A14V) according to ISO 5832-3.

# Intended Use

## Hardware

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 patientspecific preoperative CT scans.

Tornier SAS. BLUEPRINT™ Patient Specific Instrumentation

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Image /page/5/Picture/0 description: The image shows the word "TORNIER" in a large, blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of it. The letter "T" is also blue and is made up of two concentric hexagons. The logo is simple and modern.

### Software

The BLUEPRINT™ 3D Planning Software is intended to be used as a medical software to assist in pre-operative surgical planning for shoulder surgery.

# Indications For Use

### 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™ 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 orthopedic 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 guides 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 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.

## Comparison to Predicate Device

The subject device BLUEPRINT™ Patient Specific Instrumentation and the predicate device BLUEPRINT™ Patient Specific Instrumentation (K162800) have the same intended use, similar principal of operation and similar general technological features.

The subject device has similar manual segmentation as the reference device PROPHECY INVISION Pre-operative Navigation System.

Differences for subject BLUEPRINT™ Patient Specific Instrumentation include:

- For the hardware: nonfunctional dimensions, addition of a new guide reference similar to the predicate device, and packaging/label changes for clarity
Tornier SAS. BLUEPRINT™ Patient Specific Instrumentation

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Image /page/6/Picture/0 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 letter "T" inside. The letter "T" is also blue and has a smaller version of itself inside.

- For the software, additional measurements, interaction with an application for automatic processing and an application for manual processing, and additional compatible Wright-Tornier implants.
# Performance data

Technological differences between the subject and predicate hardware devices are supported by the dimensional and cadaveric tests performed on the predicate device hardware (K162800) which remain applicable to the subject hardware device as the changes to the subject device do not impact functional dimensions or material.

Technological differences between the subject and predicate software devices 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.

# Substantial equivalence conclusion

The subject device, 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 (K162800, cleared June 10, 2016).