(46 days)
Not Found
No
The 510(k) summary describes a knee resurfacing system made of standard materials and does not mention any AI/ML components, image processing, or data-driven performance metrics.
Yes
The device is an implant for arthroplasty, which is a medical procedure to restore joint function and alleviate pain, thus providing therapy.
No
The device description indicates it is a patellofemoral arthroplasty system (knee implant) made of polyethylene, used for treatment, not for diagnosing a condition.
No
The device description explicitly states the components are manufactured from polyethylene and stainless steel, indicating a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating degenerative arthritis and other conditions in the knee. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of polyethylene and stainless steel, designed to be surgically implanted. This is consistent with a medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Focus on Treatment: The entire description revolves around replacing or resurfacing parts of the knee joint to alleviate pain and improve function.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
Product codes
KRR
Device Description
The patella components are to be used with the existing Prelude PF Knee Resurfacing System. The components manufactured from polyethylene (UHMWPE) conforming to ASTM F-648 with a stainless steel x-ray wire and consist of larger sized patella options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur, patellofemoral
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 Tests:
- Engineering Analysis of the larger patellae demonstrate that the proposed additional sizes to the Prelude PF Knee Resurfacing System patellae do not raise any new risks compared to the predicate Prelude PF Knee Resurfacing System patellae.
Clinical Tests:
- None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2015
Biomet Incorporated Mr. Jared Cooper Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K143543 Trade/Device Name: Prelude PF Patellae 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: December 9, 2014 Received: December 15, 2014
Dear Mr. Cooper:
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
1
Page 2 - Mr. Jared Cooper
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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" (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 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 vours.
Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Prelude PF Patellae
Indications for Use (Describe)
The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Prelude PF Patellae 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jared Cooper, PhD
Regulatory Affairs Specialist
Biomet Sports Medicine
Phone: (574) 267-6639
Fax: (574)267-8137 |
| Date: | December 9, 2014 |
| Subject Device: | Trade Name: Prelude PF Patellae
Common Name: Unicondylar Knee Prosthesis
Classification Name:
• KRR- Prosthesis, Knee, Patello/Femoral, Semi-constrained
Cemented, metal/polymer (21 CFR §888.3540) |
Legally marketed devices to which substantial equivalence is claimed:
Device Description
The patella components are to be used with the existing Prelude PF Knee Resurfacing System. The components manufactured from polyethylene (UHMWPE) conforming to ASTM F-648 with a stainless steel x-ray wire and consist of larger sized patella options.
Intended Use and Indications for Use
The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
Summary of Technological Characteristics
4
BIOMET
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The proposed and predicate Prelude PF Knee Resurfacing System patellae devices have the identical intended use.
- Indications for Use: The proposed and predicate Prelude PF Knee Resurfacing System patellae devices have identical indications for use.
- Materials: The proposed and predicate Prelude PF Knee Resurfacing System patellae devices are manufactured from UHMWPE conforming to ASTM F648.
- Design Features: The proposed and predicate patellae devices incorporate identical design features.
- Sterilization: The proposed and predicate Prelude PF Knee Resurfacing System patellae devices are provided sterile via identical sterilization methods for single-use.
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
- o Engineering Analysis of the larger patellae demonstrate that the proposed additional sizes to the Prelude PF Knee Resurfacing System patellae do not raise any new risks compared to the predicate Prelude PF Knee Resurfacing System patellae.
- . Clinical Tests
- o None
Substantial Equivalence Conclusion
The proposed Prelude PF Knee Resurfacing System patellae have identical intended use, indications for use, and design as the predicate devices. Engineering analysis demonstrates the Prelude PF patellae do not raise any new risks compared to the legally marketed predicate devices.