(227 days)
Not Found
No
The summary describes a mechanical implant for joint replacement and does not mention any AI or ML components or functionalities.
Yes
The device is a prosthesis designed to replace the patellofemoral joint, which is a therapeutic intervention for conditions like degenerative arthritis and patellofemoral dislocation.
No
Explanation: The device is a prosthesis intended for joint replacement, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "semiconstrained resecting prosthesis" consisting of "two components, both for cemented use only: a femoral implant and a patella." This describes physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The KNEETEC PFJ device is a prosthesis intended for the replacement of the patellofemoral joint. This is a surgical implant, not a test performed on a sample.
- Intended Use: The intended use describes the conditions for which the prosthesis is indicated (degenerative arthritis, failure of conservative procedures, dislocation, post-traumatic arthritis). These are conditions that lead to the need for a physical replacement of the joint, not conditions diagnosed through laboratory testing.
Therefore, the KNEETEC PFJ device is a surgical implant and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The replacement of the patellofemoral joint with the KNEETEC PFJ device is indicated in the case of symptoms and serious signs affecting daily activities involving the joint: Serious degenerative arthritis of the patellofemoral joint, Failure of conservative procedures (realignment, arthroscopy, transfer of the tibial tuberosity) with the persistence of joint pain or dysfunction, Patellofemoral dislocation (dysplastic or other origin), Post-traumatic arthritis (patellar fracture).
The KNEETEC PFJ patellofemoral prosthesis is intended for cemented use only.
When used in association with the KNEETEC PFJ prosthesis, the patellar component of the HLS KNEETEC has the above mentioned indications for use.
The HLS KNEETEC is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also intended for the revision of knee prostheses.
The HLS KNEETEC is intended for cemented use only.
When used in association with the KNEETEC PFJ prosthesis, the patellar component of the HLS KNEETEC has the following indications for use:
The replacement of the patellofemoral joint with the KNEETEC PFI device is indicated in the case of symptoms and serious signs affecting daily activities involving the joint:
- Serious degenerative arthritis of the patellofemoral joint,
- Failure of conservative procedures (realignment, arthroscopy, transfer of the tibial tuberosity) with the persistence of joint pain or dysfunction.
- Patellofemoral dislocation (dysplastic or other origin),
- Post-traumatic arthritis (patellar fracture).
The KNEETEC PFJ patellofemoral prosthesis is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
87 KRR
Device Description
The Kneetee PFJ is a semiconstrained resecting prosthesis intended for replacement of the patellofemoral joint. The prosthesis consists of two components, both for cemented use only: a femoral implant and a patella. The patella of the knee joint may be resurfaced with the HLS KNEETEC patellar component and a substantially equivalent in K094013) or KNEETEC PFJ patellar implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patellofemoral joint, knee
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)
Non-clinical testing has been performed on the smallest components of the ranges (worst case): Contact area and trajectories of the patella to compare the congruence of the patella with the trochlea, Contact pressure test, Measurement of the subluxation force.
Results: there is no significant difference between the results for Kneetec PFJ prosthesis and the predicate devices. The results of engineering studies referenced in this 510(k) submission demonstrate the Kneetec PFJ is substantially equivalent to the predicate devices.
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.
K010100, K020841, K041160, K051948, K051086, K094013
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.
Not Found
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
§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(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)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(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,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”
0
Image /page/0/Picture/1 description: The image shows the text 'K111970' and 'Page 1' at the top. Below that, the word 'TORNIE' is written in large, bold, sans-serif font. The text appears to be part of a document or label.
Summary of Safety and Effectiveness information
510(k) Premarket Notification - KNEETEC PFJ
Date prepared: November 4th, 2011
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
KNEETEC PFJ & HLS KNEETEC patellar component Trade name: Common name: Patellofemoral knee prosthesis Classification name: 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis
2) Submitter
Tornier Rue Doyen Gosse 38330 Saint Ismier - France
3) Appliquant
Tornier 7701 France avenue South Suite 600 Edina MN 55345 - USA
4) Company contact
Tomier Mrs Stephanie BERNARD Regulatory Affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: + 33 (0)4 76 61 35 00 Fax: + 33 (0)4 76 61 35 59 e-mail: stephanie.bernard(@)tornier.fr
5) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | 87 KRR |
6) Equivalent / Predicate device
Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Corp, K010100, K020841, K041160, K051948 Patello-Femoral Knee Implant, Journey, Smith & Nephew, Inc, K051086 HLS Kneetec, Tornier, K094013
Tél. : 33 (0)4 76 61 35 00 TORNIER S.A.S. Fax : 33 (0)4 76 61 35 33 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Section 5 - Page 1/ page 3
S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
1
K11/1970 Page
TORNIER
7) Device description
The Kneetee PFJ is a semiconstrained resecting prosthesis intended for replacement of the patellofemoral joint. The prosthesis consists of two components, both for cemented use only: a femoral implant and a patella. The patella of the knee joint may be resurfaced with the HLS KNEETEC patellar component and a substantially equivalent in K094013) or KNEETEC PFJ patellar implant.
8) Materials
The femoral implant is manufactured from chromium cobalt alloy (CoCr) according to ISO standard 5832-7 or 5832-12. The patella is made of ultra high molecular weight polyethylene (UHMWE) according to ISO standard 5834-2.
9) Indications for use
The replacement of the patellofemoral joint with the KNEETEC PFJ device is indicated in the case of symptoms and serious signs affecting daily activities involving the joint:
- Serious degenerative arthritis of the patellofemoral joint,
- Failure of conservative procedures (realignment, arthroscopy, transfer of the tibial tuberosity) with the persistence of joint pain or dysfunction,
- Patellofemoral dislocation (dysplastic or other origin),
- Post-traumatic arthritis (patellar fracture),
The KNEETEC PFJ patellofemoral prosthesis is intended for cemented use only.
When used in association with the KNEETEC PFJ prosthesis, the patellar component of the HLS KNEETEC has the above mentioned indications for use.
| Main features or
system characteristics | Kneetec
PFJ | HLS Kneetec | Avon | Journey |
|--------------------------------------------|-----------------------------------------------|-----------------------------------------------|--------------------------------------------|--------------------------------------------|
| Materials
Femoral part | CoCr alloy
ISO 5832-7
or
ISO 5832-12 | CoCr alloy
ISO 5832-7
or
ISO 5832-12 | CoCr alloy | Oxinium |
| Materials
Patellar
component | UHMWPE
ISO 5834-2 | UHMWPE
ISO 5834-2 | UHMWPE | UHMWPE
ASTM F 648 |
| Method of fixation | Cemented | Cemented | Cemented | Cemented |
| Intended use | Replacement of the
patellofemoral joint | Total knee prosthesis | Replacement of the
patellofemoral joint | Replacement of the
patellofemoral joint |
| Terminal sterilization | Gamma | Gamma | N/K | N/K |
| Manufacturer | TORNIER | TORNIER | Stryker | Smith & Nephew |
| K-number | K111970 | K094013 | K010100
K020841
K041160
K051948 | K051086
K951987 |
10) Summary of technological characteristics
Image /page/1/Picture/16 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and appears to be constructed from geometric shapes. The logo is black and white, with the 'T' and the outline of the hexagon being black against a white background.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
Section 5 - Page 2/ page 3
SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
2
K111970 Page
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TORNIER
11) Non-clinical testing
The following non-clinical testing has been performed on the smallest components of the ranges (worst case):
- Contact area and trajectories of the patella to compare the congruence of the patella with the । trochlea,
- Contact pressure test, -
- Measurement of the subluxation force. r
Results: there is no significant difference between the results for Kneetec PFJ prosthesis and the predicate devices.
The results of engineering studies referenced in this 510(k) submission demonstrate the Kneetec PFJ is substantially equivalent to the predicate devices.
12) Substantial equivalence conclusion
Substantial equivalence of the Kneeter PFJ to the already cleared Avon, Journey and HLS Kneeter prostheses can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:
- The components of the Kneetec PFJ have been compared to the predicate devices.
- The components of the Kneeter PFJ have the same intended use as the Avon and Journey prostheses and very similar indications for use.
- Major technological characteristics are equivalent between the Kneetec PFJ and the predicate devices: -
- Equivalence of general features and material, י
- Equivalence of non-clinical testing results, .
- -Equivalence of range of motion,
- Equivalent means of fixation, .
- Equivalent prosthetic dimensions. -
Therefore, in light of the above information, the company believes that the components of the Kneeter PFJ and the patellar component of the HLS Kneetec may be cleared via the 510(k) notification process for use as a Patellofemoral Knee Prosthesis.
Image /page/2/Picture/21 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and has a unique design, with the top part of the 'T' appearing to be a smaller, inverted hexagon. The logo is simple and geometric, with a focus on the letter 'T' as the central element.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
Section 5 - Page 3/ page 3
S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
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 caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 3 2012
Tornier, Incoporated % Ms. Stéphanie Bernard Regulatory Affairs Specialist 161, rue Lavoiser - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Re: K111970
Trade/Device Name: Kneetec PFJ & HLS Kneetec Patellar Component Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KRR Dated: February 10, 2012 Received: February 13, 2012
Dear Ms. Bernard:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved above and have determined the device is substantially equivalent (for the indications ferenced above and har sure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to ttg_segactment date of the Medical Device Amendments, or to conniner of the 11th) 2011-11-11 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). and Cosmetic (10. (110.) has the device, subject to the general controls provisions of the Act. The 1 ou may, morelore, manot of the Act include requirements for annual registration, listing of general voltrold providering practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (boo above) insting major regulations affecting your device can be may be subject to additions, 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 i lease oc advised that I Dri bristian that your device complies with other requirements of the Act that I Drinas made a cond regulations administered by other Federal agencies. You must of any I catal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 - Ms. Stéphanie Bernard
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 rood ct 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/CDRHOffices/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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K111970 Page 1/2
Indications for Use
K111970 510(k) Number (if known): K111970
Device Name: KNEETEC PFJ
Indications For Use:
The replacement of the patellofemoral joint with the KNEETEC PFJ device is indicated in the case of symptoms and serious signs affecting daily activities involving the joint:
-
Serious degenerative arthritis of the patellofemoral joint,
-
Failure of conservative procedures (realignment, arthroscopy, transfer of the tibial tuberosity) with the persistence of joint pain or dysfunction,
-
Patellofemoral dislocation (dysplastic or other origin),
-
Post-traumatic arthritis (patellar fracture).
The KNEETEC PFJ patellofemoral prosthesis is intended for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (2) 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)
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page 1 of 1
Section 4
Tomier
6
K111970 Page 2/2
Indications for Use
K111970 510(k) Number (if known): K094013
Device Name: HLS KNEETEC patellar implant
Indications For Use:
The HLS KNEETEC is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also intended for the revision of knee prostheses.
The HLS KNEETEC is intended for cemented use only.
When used in association with the KNEETEC PFJ prosthesis, the patellar component of the HLS KNEETEC has the following indications for use:
The replacement of the patellofemoral joint with the KNEETEC PFI device is indicated in the case of symptoms and serious signs affecting daily activities involving the joint:
-
Serious degenerative arthritis of the patellofemoral joint,
-
Failure of conservative procedures (realignment, arthroscopy, transfer of the tibial tuberosity) with the persistence of joint pain or dysfunction.
-
Patellofemoral dislocation (dysplastic or other origin),
· Post-traumatic arthritis (patellar fracture).
The KNEETEC PFJ patellofemoral prosthesis is intended for cemented use only.
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)
| (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices | Page 1 of 1 | |
|---|---|---|
| Tornier | 510(k) Number | Section 4 |
| K111970 |