(133 days)
Not Found
No
The summary describes a traditional knee implant system with no mention of AI or ML in its intended use, device description, or performance studies.
Yes.
The device is an implantable prosthetic used to treat degenerative arthritis, patellar dislocation, or patella fracture, which falls under the definition of a therapeutic device.
No
The device is an implant for patellofemoral arthroplasty, which is a treatment, not a diagnostic procedure. Its intended use is described as "cemented patellofemoral arthroplasty in patients with degenerative arthritis...".
No
The device description explicitly states it consists of physical components (CoCrMo patellofemoral component and ultra-high molecular weight polyethylene patella components) intended for implantation.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a surgical implant system (patellofemoral knee implant) that is surgically implanted into the body to replace damaged joint surfaces. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
The information clearly indicates this is a medical device intended for surgical implantation, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The MAKO Surgical Corp. Patellofemoral Knee Implant System is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, 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 (comma separated list FDA assigned to the subject device)
87 KRR
Device Description
This device consists of a CoCrMo patellofemoral component and an ultra-high molecular weight polyethylene patella components are intended for cemented, one-time use only. The anterior surface of the patellofemoral component is polished and features a trochlear groove. The posterior surface of the patellofemoral and patella component employ features such as cement pockets and pegs for enhanced stability of the prosthesis when cemented onto the femur and patella, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee - distal femur and patella
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)
Not Found
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.
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
080029 '/2
MAY 1 6 2008
2555 Davie Road • Ft. Lauderdale, Fl. 33317 • Phone 954.927.0446 • Www.makosurgical.com .
ATTACHMENT 2
510(K) SUMMARY
| Submitter: | MAKO Surgical Corp. |
|---|---|
| Address: | 2555 Davie Road, Fort Lauderdale, FL 33317 |
| Phone number / Fax Number: | (Ph) 954-927-2044 x 605; (F) 954-927-0446 |
| Contact Person: | William F. Tapia |
| Date Prepared: | May 14, 2008 |
| Proprietary Name: | MAKO Surgical Corp. Patellofemoral Knee Implant System |
| Common Name: | Patellofemoral replacement, patellofemoral knee system |
| Classification Name / #: | Class II; 21 CFR 888.3540 |
| Product Code: | 87 KRR – Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis |
Substantial Equivalence: The MACO Surgical Corp. Patellotent System is substanialiy equivalen
to Styler Corporation's Avon" Patello-femoral Joint - Roth100; Avon"" Paleller (510k # K051948).
| Feature | MAKO Surgical Corp. Patellofemoral Knee Implant System |
|---|---|
| Intended Use/Indications for | |
| Use | The MAKO Surgical Corp. Patellofemoral Knee Implant System is intended to be |
| used in cemented patello-femoral arthroplasty in patients with degenerative | |
| arthritis in the distal femur and patella, 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. | |
| Implant Components | • Patellofemoral component - CoCr |
| • Patella component - UHMWPE | |
| • Radiographic o-ring in patella component | |
| Sizes | • Patellofemoral components available in 8 sizes. |
| • The patella components are available in 6 sizes | |
| Materials | • Patellofemoral component - CoCr |
| • Patella component - UHMWPE | |
| • Radiographic o-ring marker - titanium wire | |
| Instrumentation | Provided separately in a re-usable/sterilizable tray. Tray includes various tools |
| (e.g., sizers, templates, trials, drill, gage, impactors, inserters, extractors) used | |
| during surgery. | |
| Sterilization and Packaging | Sterilization: |
| • Patellofemoral and patella components -- gamma radiation | |
| • Instrumentation - steam sterilization | |
| Packaging: | |
| • Both patellofemoral and patella components are supplied in double | |
| sealed containers maintaining double sterile barriers. | |
| Biocompatibility | Both devices are made of materials for surgical implant applications per |
| recognized ASTM standards. |
Description: This device consists of a CoCrMo patellofemoral component and an ultra-high molecular weight polyethylene patella components are intended for cemented, one-time use only. The anterior surface of the patellofemoral component is polished and features a trochlear groove. The posterior surface of the patellofemoral and patella component employ features such as cement pockets and pegs for enhanced stability of the prosthesis when cemented onto the femur and patella, respectively.
1
YC080029
Image /page/1/Picture/1 description: This image contains a handwritten fraction. The numerator is the number 2, and the denominator is also the number 2. The fraction is written in a simple, clear style. The image is a close-up of the fraction.
MAKO
SURGICAL CORP.
2555 Davie Road __ Ft. Lauderdale, FL 33312 . Phone 954.927.0446 · www.makosurgical.com...
Intended Use/Indications for Use: The MAKO Surgical Corp. Patellofemoral Knee Implant System is intended to be used in cemented patellofenoral arthroplasty in patients with december arthritis in the distal femur and atella, patients with a history of patellar dislocation or patients with failed previous surgent archite previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
These components are single use only and are intended for implantation with bone cement.
2
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAKO Surgical Corp. % William F. Tapia 2555 Davie Road Suite 110 Ft. Lauderdale, FL 33317
MAY 1 6 2008
Re: K080029 Trade/Device Name: MAKO Surgical Corp. Patellofemoral Knee Implant System 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: May 14, 2008 Received: May 15, 2008
Dear Mr. Tapia:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Pagc 2 - William F. Tapia
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark W. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo consists of the word "MAKO" in large, bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font below. Above the word "MAKO" is a stylized graphic element that resembles a wave or a mountain range. The graphic element is filled with a textured pattern.
2555 Davie Road • Ft. Lauderdale, FL 33317_ • Phone 954.927.0446 • www.makosurgical.com
EXHIBIT G
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MAKO Surgical Corp. Patellofemoral Knee Implant System
Indications for Use:
The MAKO Surgical Corp. Patellofemoral Knee Implant 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.
These components are single use only and are intended for implantation with bone cement.
Prescription Use × (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)
Neil R.P. del Gormon
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K080029