(28 days)
No
The document describes a mechanical shoulder implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are bench tests related to the physical properties of the implant.
Yes
The device is a joint replacement system (Affiniti Total and Hemi-Shoulder System) intended to alleviate pain and disability caused by various shoulder conditions like arthritis and fractures, thereby restoring function. This directly aligns with the definition of a therapeutic device, which is designed to treat or manage a disease or condition.
No
This device is a shoulder implant system (Affiniti Total and Hemi-Shoulder System) used for surgical treatment of joint conditions, not for diagnosing them.
No
The device description clearly outlines physical components like humeral stems, humeral heads, and glenoids, which are hardware implants for shoulder arthroplasty.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant system (humeral stem, humeral heads, glenoids) intended to replace or repair damaged shoulder joints. It is used in the body during surgery, not to test samples from the body.
- Performance Studies: The performance studies described are bench tests related to the mechanical properties and durability of the implant (fatigue testing, tensile test, shear test, etc.), not studies evaluating the accuracy of a diagnostic test.
Therefore, based on the provided information, the Affiniti Total and Hemi-Shoulder System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Affiniti Total and Hemi-Shoulder System are indicated for:
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
-
- Fracture/dislocations of the proximal humerus; where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
The Affiniti Hemi-Shoulder System is also indicated for:
-
- Ununited humeral head fractures.
-
- Avascular necrosis of the humeral head.
-
- Rotator cuff tear arthropathy.
Notes:
- Glenoid components are labeled "for cemented use only" and are indicated only for use with . bone cement.
- Humeral stems are indicated for press-fit un-cemented use or for use with bone cement. .
- . This is a single use device.
Product codes (comma separated list FDA assigned to the subject device)
KWS, HSD
Device Description
The sterile Affiniti Total and Hemi-Shoulder System is comprised of a :
- Humeral stem, .
- Humeral heads in two styles (standard and eccentric) .
- Glenoids in two styles (pegged or keeled). .
The humeral heads mate on the stems through a locking taper. The humeral heads are highly polished and articulate with the glenoids.
The humeral stems are offered in two versions Non-coated humeral stems and Porous coated humeral stems :
- Non-Porous coated humeral stems and Porous coated humeral stems are offered . . I in two lengths:
- o Standard
- o long
The humeral heads are available in:
- 15 standard sizes .
- . 10 eccentric sizes
- 8 extended head sizes (Product line addition to K060988 via K073331) .
The Glenoid is available in multiple sizes in 2 different configurations(pegged or keeled).
- This submission corresponds to a change made to the Affiniti Total and Hemi-. Shoulder System (previously cleared in 510(k) K060988), The change correspond to the addition of a porous coated to Humeral stems of the Affiniti Shoulder System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The modifications made to the proposed Tornier Inc. Affiniti Total and Hemi-Shoulder System were verified and validated by performing:
- Bench test: .
- Fatigue testing 0
Porous coating Characterisation and evaluation: . - Static Tensile Test O
- Static Shear Test 0
- Shear Fatigue Test O
- Bending Fatigue Test 0
- Abrasion Resistance Test o
The results of those evaluations allow us to conclude that the proposed Tornier Inc. Affiniti Total and Hemi-Shoulder described in this submission does not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent.
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.
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
SECTION 5
NOV - 9 2010
ﺴﺴ ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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Special 510(k) Premarket Notification : , October 8 2010 Summary of Safety and Effectiveness information
Tornier Inc. Affiniti Total and Hemi-Shoulder System
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
| Trade name: | Affiniti Total and Hemi-Shoulder System
Affiniti Shoulder System |
|------------------------|----------------------------------------------------------------------------------------------------------------------|
| Common name: | Shoulder prosthesis, humeral head |
| Classification name: | Shoulder joint metal/polymer semi-constrained cemented
Shoulder joint humeral (hemi-shoulder) metallic uncemented |
| Classification number: | 888.3660 and 888.3690 |
2) Submitter
Tornier Inc. 7701 France Ave. S, Suite 600 Edina, MN 55435 Registration Number: 9100540
3) Company contact
Brahim Hadri
Sr. Regulatory Affairs Specialist 100 Cummings Center, Suite 444C, Beverly, MA 01915, U.S.A Phone: 1 978 232-9997 ext: 617 1 978-232-9998 Fax:
4) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | KWS and HSD |
510(k) Submission: Tornier Inc. Affiniti Total and Hemi-Shoulder System
1
5) Equivalent / Predicate device
- Tornier DVO Total and Hemi Shoulder System: K060988 .
Note:
- The Tornier DVO Total and Hemi Shoulder System (K060988) is presently o named Affiniti Total and Hemi-Shoulder System and hereafter will be referred to as such.
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
:
、
6) Device description
The sterile Affiniti Total and Hemi-Shoulder System is comprised of a :
- Humeral stem, .
- Humeral heads in two styles (standard and eccentric) .
- Glenoids in two styles (pegged or keeled). .
The humeral heads mate on the stems through a locking taper. The humeral heads are highly polished and articulate with the glenoids.
The humeral stems are offered in two versions Non-coated humeral stems and Porous coated humeral stems :
- Non-Porous coated humeral stems and Porous coated humeral stems are offered . . I in two lengths:
- o Standard
- o long
The humeral heads are available in:
- 15 standard sizes .
- . 10 eccentric sizes
- 8 extended head sizes (Product line addition to K060988 via K073331) .
The Glenoid is available in multiple sizes in 2 different configurations(pegged or keeled).
- This submission corresponds to a change made to the Affiniti Total and Hemi-. Shoulder System (previously cleared in 510(k) K060988), The change correspond to the addition of a porous coated to Humeral stems of the Affiniti Shoulder System.
510(k) Submission: Tornier Inc. Affiniti Total and Hemi-Shoulder System
Page 2 of 3
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-103007
7) Materials
Materials include titanium humeral stems (some stems coated with pure titanium); cobalt chrome humeral heads and ultrahigh molecular weight polyethylene glenoids.
8) Indications
The Affiniti™ Total and Hemi-Shoulder System are indicated for:
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
-
- Fracture/dislocations of the proximal humerus; where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
The Affiniti™ Hemi-Shoulder System is also indicated for:
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
-
- Rotator cuff tear arthropathy.
Notes:
- Glenoid components are labeled "for cemented use only" and are indicated . only for use with bone cement.
- Humeral stems are indicated for press-fit un-cemented use or for use with bone . cement.
. İ
..
, f
: :
- This is a single use device. .
9) Substantial Equivalence
The modifications made to the proposed Tornier Inc. Affiniti Total and Hemi-Shoulder System were verified and validated by performing:
- Bench test: .
- Fatigue testing 0
Porous coating Characterisation and evaluation: .
- Static Tensile Test O
- Static Shear Test 0
- Shear Fatigue Test O
- Bending Fatigue Test 0
- Abrasion Resistance Test o
The results of those evaluations allow us to conclude that the proposed Tornier Inc. Affiniti Total and Hemi-Shoulder described in this submission does not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent.
510(k) Submission: Tornier Inc. Affiniti Total and Hemi-Shoulder System
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tornier, Inc. % Mr. Brahim Hadri Senior Regulatory Affairs Specialist 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915
NOV - 9 2010
Re: K103007
Trade/Device Name: Affiniti Total and Hemi-Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: October 12, 2010 Received: October 12, 2010
Dear Mr. Hadri:
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
4
Page 2 - Mr. Brahim Hadri
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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours.
Вавваевиченко
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
10 300 7
510(k) Number (if known):
Device Name: Affiniti Total and Hemi-Shoulder System
NOV - 9 2010
Indications For Use:
The Affiniti Total and Hemi-Shoulder System are indicated for:
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
-
- Fracture/dislocations of the proximal humerus; where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
The Affiniti Hemi-Shoulder System is also indicated for:
-
- Ununited humeral head fractures.
-
- Avascular necrosis of the humeral head.
-
- Rotator cuff tear arthropathy.
Notes:
- Glenoid components are labeled "for cemented use only" and are indicated only for use with . bone cement.
- Humeral stems are indicated for press-fit un-cemented use or for use with bone cement. .
- . This is a single use device.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Submissjon: Tornier Inc. Affiniti Total and Hemi-Shoulder System
Harboe Buent
(Division Sign-Off) Division of Surgic J. Orthopedic, and Restorative Devices
510(k) Number K103007
Page 10 of 66
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