(140 days)
No
The description focuses on standard pre-surgical planning software functionalities like visualization, measurement, reconstruction, annotation, editing, and guide design based on surgeon input and CT data. There is no mention of AI/ML techniques for image analysis, automated decision-making, or predictive modeling. The validation is based on nonclinical testing and equivalence to predicate devices, not performance metrics typically associated with AI/ML models.
No.
A therapeutic device is one that directly treats a disease or condition. This device is a planning and guiding system used during surgery, which is an adjunctive tool for a therapeutic procedure rather than a therapeutic device itself.
No
The "Intended Use / Indications for Use" section explicitly states "BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose."
No
The device description explicitly states that the BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software). While the software is a component, the overall device system includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The BLUEPRINT™ Patient Specific Instrumentation is a system used for pre-surgical planning and intraoperative guidance during shoulder arthroplasty. It uses CT scan images to create patient-specific guides for implant placement.
- Lack of Biological Sample Testing: The device does not involve the testing of any biological samples from the patient. Its function is based on analyzing anatomical data from imaging.
- Explicit Statement: The software description explicitly states: "BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose." While this doesn't directly state it's not an IVD, it reinforces that its purpose is not diagnostic testing of biological samples.
Therefore, the BLUEPRINT™ Patient Specific Instrumentation falls under the category of surgical planning and guidance devices, not In Vitro Diagnostics.
N/A
Intended Use / 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 surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT™ 3D Planning Software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems.
The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 3D Planning Software allows surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows surgeon to design glenoid patient-specific guides based on the pre-surgical plan.
The software leads to the generation of a surgery report along with a 3D file of the glenoid patient-specific guide.
BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide.
BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).
Hardware
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 by the BLUEPRINTTM 3D Planning Software. All BLUEPRINT™ Glenoid Guides are patient-specific, single use and delivered non-sterile.
Software
BLUEPRINT™ 3D Planning Software is composed of one software component connected to an Online Management System (OMS). The software 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 plan an operation by allowing surgeons to:
- Position and select glenoid implant,
- Position and select humeral implant,
- Display bone density and reaming surface,
- Simulate the prosthetic range of motion,
- Design a patient specific guide for the glenoid component.
Mentions image processing
BLUEPRINT™ 3D Planning Software allows surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan (Computed Tomography)
Anatomical Site
shoulder
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
orthopedic surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) was validated through nonclinical testing for the BLUEPRINT 3D Planning Software.
The validation of BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) was already proven via BLUEPRINT™ Patient Specific Instrumentation (K143374) and BLUEPRINT™ Patient Specific Instrumentation (K160555), including polyamide and titanium materials, when used for helping the positioning of the Aequalis PerFORM (K111902) implant. The performed testing for validation of the design, manufacturing, biocompatibility, sterility, dimensions and the accuracy of the guide are applicable to the subject device. Technical, clinical and biological equivalences have been demonstrated in order to use BLUEPRINT™ Glenoid Guides with additional WRIGHT-TORNIER implants such as Aequalis PerFORM+ (K160975) and Aequalis Reversed II (K151293).
All BLUEPRINT™ Glenoid Guides aim to drill a K-wire guiding the main reaming, regardless of the implant planned. All BLUEPRINT™ Glenoid Guides have exactly the same design, except BLUEPRINT™ Glenoid Guides in titanium dedicated to be used with Aequalis PerFORM (K111902) and Aequalis PerFORM+ (K160975) implants which include an orientation hole for controlling rotation of the implant (cleared via BLUEPRINTTM Patient Specific Instrumentation (K160555)).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K153602, K160001, K132636, K101342
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2017
TORNIER SAS Aymen Azaiez Regulatory Affairs Specialist 161 rue Lavoisier 38330 Montbonnot Saint Martin France
Re: K162800
Trade/Device Name: 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: KWS Dated: September 30, 2016 Received: October 5, 2016
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
BLUEPRINT 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 surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT™ 3D Planning Software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems.
The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 3D Planning Software allows surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows surgeon to design glenoid patient-specific guides based on the pre-surgical plan.
The software leads to the generation of a surgery report along with a 3D file of the glenoid patient-specific guide.
BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide.
BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/0 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, blue font. Below that, the words "Implants Chirurgicaux" are in a smaller, bold, blue font.
510k Summary
Traditional 510(k) Premarket – BLUEPRINT™ Patient Specific Instrumentation
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
| Trade name: | BLUEPRINT™ Patient Specific Instrumentation |
|---|---|
| Common name: | Patient Specific Instrumentation + 3D Planning Software |
| Classification name: | Prosthesis, Shoulder, Semi-constrained, Metal/Polymer Cemented |
| ($888.3660) |
2) Submitter
TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034
3) Company contact
TORNIER SAS Mr Aymen AZAIEZ Regulatory Affairs Specialist 161 rue Lavoisier 38334 Montbonnot Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 Email: aymen.azaiez(@wright.com
4) Classification
Device class: Class II Classification panel: Orthopedic Product code: KWS
5) Primary Predicate Device and Reference devices
| Trade name | 510(k) Number | Decision date | Applicant |
|---|---|---|---|
| BLUEPRINT™ Patient Specific | |||
| Instrumentation | |||
| (PRIMARY) | K160555 | 10th June 2016 | TORNIER SAS |
| Materialise Glenoid Positioning System | |||
| (Reference) | K153602 | 26th April 2016 | MATERIALISE NV |
| TraumaCad Mobile Release 2.0 (Reference) | K160001 | 12th February 2016 | VOYANT HEALTH LTD |
| DYONICS PLAN HIP IMPINGEMENT | |||
| PLANNING SYSTEM (Reference) | K132636 | 17th October 2016 | SMITH & NEPHEW, INC |
| OSIRIX MD (Reference) | K101342 | 20th August 2010 | PIXMEO SARL |
Image /page/4/Picture/14 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light blue color and appears to be constructed from geometric shapes, giving it a modern and abstract look. The hexagon provides a border around the 'T', further defining the logo's shape and structure. The overall design is simple, clean, and easily recognizable.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
5
6) Device description
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).
Hardware
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 by the BLUEPRINTTM 3D Planning Software. All BLUEPRINT™ Glenoid Guides are patient-specific, single use and delivered non-sterile.
Software
BLUEPRINT™ 3D Planning Software is composed of one software component connected to an Online Management System (OMS). The software 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 plan an operation by allowing surgeons to:
- Position and select glenoid implant,
- Position and select humeral implant,
- Display bone density and reaming surface, ●
- Simulate the prosthetic range of motion, 0
- Design a patient specific guide for the glenoid component. o
7) Materials
The commercially available BLUEPRINT™ Glenoid Guides are manufactured from medical grade polyamide (PA 2200) or titanium (Ti6Al4V).
8) 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 patient-specific 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.
Image /page/5/Picture/21 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is formed by two overlapping shapes, creating a three-dimensional effect. The color of the logo is a light shade of purple or blue. The logo appears to be simple and modern.
TORNIER S.A.S. 161. rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
6
Image /page/6/Picture/0 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, dark blue font. Below that, the words "Implants Chirurgicaux" are in a smaller, dark blue font.
9) Indications
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 surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT™ 3D Planning Software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems.
The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 3D Planning Software allows surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows surgeon to design glenoid patient-specific guides based on the pre-surgical plan.
The software leads to the generation of a surgery report along with a 3D file of the glenoid patient-specific guide.
BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide.
BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose.
10) Summary of technological characteristics
BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) has an equivalent intended use and the same fundamental scientific technology as the primary predicate and reference devices. The subject device is intended for total shoulder arthroplasty, (same as the predicate device) and for reverse shoulder arthroplasty (same as the reference device Materialise Glenoid Positioning System (K153602)). The subject device is equivalent to the predicate device for the main technological characteristics. Additionally, the subject device is equivalent to reference devices:
- Voyant Health, Ltd. TRAUMACAD VERSION 2.0 (K160001) for the humeral planning functionality -
- The Smith & Nephew DYONICS PLAN Hip Impingement Planning System (K132636) for the range of motion functionality
- -PIXMEO SARL OsiriX MD (K101342) for the bone density functionality
The design differences have been demonstrated to not affectiveness or raise new issues of safety or effectiveness.
Image /page/6/Picture/18 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is composed of two overlapping shapes, creating a layered effect. The color of the logo is a light shade of purple or blue. The overall design is simple and modern.
TORNIER S.A.S. 161. rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
7
Implants Chirurgicau
11) Performance data
BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) was validated through nonclinical testing for the BLUEPRINT 3D Planning Software.
The validation of BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) was already proven via BLUEPRINT™ Patient Specific Instrumentation (K143374) and BLUEPRINT™ Patient Specific Instrumentation (K160555), including polyamide and titanium materials, when used for helping the positioning of the Aequalis PerFORM (K111902) implant. The performed testing for validation of the design, manufacturing, biocompatibility, sterility, dimensions and the accuracy of the guide are applicable to the subject device. Technical, clinical and biological equivalences have been demonstrated in order to use BLUEPRINT™ Glenoid Guides with additional WRIGHT-TORNIER implants such as Aequalis PerFORM+ (K160975) and Aequalis Reversed II (K151293).
All BLUEPRINT™ Glenoid Guides aim to drill a K-wire guiding the main reaming, regardless of the implant planned. All BLUEPRINT™ Glenoid Guides have exactly the same design, except BLUEPRINT™ Glenoid Guides in titanium dedicated to be used with Aequalis PerFORM (K111902) and Aequalis PerFORM+ (K160975) implants which include an orientation hole for controlling rotation of the implant (cleared via BLUEPRINTTM Patient Specific Instrumentation (K160555)).
12) Conclusion
BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) described in this section has an equivalent intended use and the same fundamental scientific technology as the cleared BLUEPRINT™ Patient Specific Instrumentation (K160555) and the reference devices.
Based on the performance data presented for the design differences between the subject and predicate device, Tornier concludes that subject device is substantially equivalent to the predicate device.
Image /page/7/Picture/8 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light purple or blue color and appears to be constructed from geometric shapes, giving it a modern and somewhat abstract look. The hexagon provides a clear border around the 'T', making it stand out against the white background. The logo is simple, clean, and likely represents a company or organization whose name begins with the letter 'T'.
TORNIER S.A.S. 161. rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A