(86 days)
-Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint;
-The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation);
-History of patellar dislocation or patella fracture;
-Dysplasia-induced degeneration
This device is intended for cemented use only.
The Zimmer Patellofemoral Joint (PFJ) Prosthesis is designed to closely replicate the anatomic features of the patellar groove on the femur. The implant's articulating surface incorporates the NexGen® knee system's frontal profile geometry for optimal patella tracking for both resurfaced and unresurfaced patellas. The construct of the PFJ prosthesis accommodates a wide range of patients, both female and male. Five sizes in left and right configurations are being offered for this implant.
Here's an analysis of the provided text regarding the Zimmer® Patellofemoral Joint Prosthesis:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided document is a 510(k) Summary for the Zimmer® Patellofemoral Joint Prosthesis (K070695). For this type of device, a 510(k) clearance is typically based on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit "acceptance criteria" and a detailed "study" in the sense of a clinical trial proving specific performance metrics against those criteria.
The acceptance criteria here would be understood as the device being as safe and effective as the predicate devices. The "study" demonstrating this involves non-clinical performance data and a comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for 510(k) Clearance) | Reported Device Performance |
|---|---|
| Safety: Device is as safe as legally marketed predicate devices. | Non-clinical testing demonstrated that the Zimmer Patellofemoral Joint Prosthesis met performance requirements and is as safe and effective as the predicate devices. The device is packaged, manufactured, and sterilized using the same materials and processes as the predicate devices. |
| Effectiveness: Device is as effective as legally marketed predicate devices. | Non-clinical testing demonstrated that the Zimmer Patellofemoral Joint Prosthesis met performance requirements and is as safe and effective as the predicate devices. It has the same intended use and similar fixation methods as the predicate devices. |
| Functional Equivalence: Device performs similarly to predicate devices. | The device is designed to replicate anatomic features of the patellar groove, incorporates existing knee system geometry for optimal patella tracking, and accommodates a wide range of patients. This functional design aims to achieve similar or improved outcomes as the predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing, which typically involves laboratory or benchtop tests on components or the complete device itself, not a patient-based "test set" in the traditional clinical trial sense.
- Data Provenance: Not applicable for a "test set" as described above. The "non-clinical testing" would have been conducted by Zimmer, Inc., likely at their facilities or by contracted testing laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. As this is a non-clinical submission, ground truth related to patient outcomes or diagnoses is not established by clinical experts for a test set. The "ground truth" relates to engineering and material specifications, and the functionality of the device as tested in a lab setting.
4. Adjudication Method for the Test Set
- Not applicable. There is no mention of a human-read test set or any adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is a type of clinical comparative study involving multiple human readers interpreting medical images, typically with and without AI assistance, across multiple patient cases. This submission is for a prosthetic device, not an imaging diagnostic tool, and the data presented is non-clinical.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable in the context of imaging algorithms. This device is a physical implant. The "standalone performance" is essentially the device's mechanical and functional performance demonstrated through non-clinical bench testing.
7. The Type of Ground Truth Used
- The "ground truth" for non-clinical testing refers to established engineering standards, biomechanical principles, material specifications, and performance targets derived from the predicate devices and general orthopedic requirements. It's based on engineering specifications and established mechanical/material properties, rather than clinical outcomes or pathology.
8. The Sample Size for the Training Set
- Not applicable. In the context of medical devices like prostheses, there isn't a "training set" in the sense of machine learning. The design and development of the device would involve iterative engineering, simulations, and prototype testing, but not a dataset used to "train" an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8. The design process is guided by anatomical studies, engineering principles, and experience with previous successful knee prosthesis designs (including the predicate devices).
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JUN - 7 2007
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Dalene T. BinkleySenior Associate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605 |
| Date: | June 4, 2007 |
| Trade Name: | Zimmer® Patellofemoral Joint Prosthesis |
| Common Name: | Knee Prosthesis Component |
| Classification Nameand Reference: | Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis21 CFR § 888.3540 |
| Predicate Device: | Stryker Compartmental Knee System, manufacturedby Howmedica Osteonics Corp., K052917, clearedDecember 27, 2005Natural-Knee® II Patellofemoral Joint Prosthesis,manufactured by Zimmer, Inc., K002356, clearedOctober 30, 2000NexGen® Knee Gender Solutions Female FemoralComponents, manufactured by Zimmer, Inc.,K060370, cleared April 28, 2006 |
| Device Description: | The Zimmer Patellofemoral Joint (PFJ) Prosthesis isdesigned to closely replicate the anatomic featuresof the patellar groove on the femur. The implant'sarticulating surface incorporates the NexGen® kneesystem's frontal profile geometry for optimal patellatracking for both resurfaced and unresurfacedpatellas. The construct of the PFJ prosthesisaccommodates a wide range of patients, both femaleand male. Five sizes in left and right configurations |
| Intended Use: | -Osteoarthritis, traumatic arthritis, polyarthritis,and/or severe chondrocalcinosis of thepatellofemoral joint;-The salvage of previously failed surgical attempts(e.g., arthroscopy, lateral release, cartilagetransplantation);-History of patellar dislocation or patella fracture;-Dysplasia-induced degenerationThis device is intended for cemented use only. |
| Comparison to Predicate Device: | The Zimmer Patellofemoral Joint Prosthesis ispackaged, manufactured, and sterilized using thesame materials and processes as the predicatedevices. The subject device also has the sameintended use and similar fixation methods as thepredicate devices. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Non-clinical testing demonstrated that the ZimmerPatellofemoral Joint Prosthesis met performancerequirements and is as safe and effective as thepredicate devices. |
:
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are being offered for this implant.
:
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2007
Zimmer, Inc. % Ms. Dalene T. Binkley M.S., RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K070695 Trade/Device Name: Zimmer® Patellofemoral Joint Prosthesis 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: March 12, 2007 Received: March 13, 2007
Dear Ms. Binkley:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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.
If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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); good manufacturing practice requirements as set
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Page 2 – Ms. Dalene T. Binkley M.S., RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your devices as described in your Section 510(k) rms lotter will and my Jorve FDA finding of substantial equivalence of your devices to a legally premation notificate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please If you desire specific acreed at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general informational and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or on the Internet address http://www.fda.gov/odrh/industry/support/index.html.
Sincerely yours,
Carbone Buehr
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® Patellofemoral Joint Prosthesis
Indications for Use:
-Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe
chondrocalcinosis of the patellofemoral joint;
chondrocalchiosis of the patchoremoral joints,
-The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation),
-History of patellar dislocation or patella fracture;
-Dysplasia-induced degeneration
This device is intended for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tenbas breens
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K070695
009
§ 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.”