(90 days)
The MAKO Surgical Corp. Patellofemoral Knee Implant System II 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. These components are single use only and are intended for implantation with bone cement.
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.
The provided text describes the MAKO Surgical Corp. Patellofemoral Knee Implant System II and its regulatory clearance, but it does not contain information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or comparative effectiveness studies).
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about the study design elements you requested, as this information is not present in the provided document.
This document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed clinical study results or performance metrics against specific acceptance criteria for a new AI/software-based medical device.
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Korois
Image /page/0/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features 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 that resembles a shark fin or a wave. The logo is black and white.
OCT 22 2008
2555 Davie Road • Et. Lauderdale, FL 33317 • Phone 954,927,2044 • Fax,954,927.0446 • www.makosurgical.com
EXHIBIT E
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: | July 22, 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 MAKO Surgical Corp. Patellofemoral Knee Implant System II (MPFII) is substantially equivalent to MAKO Surgical Corp. Patellofemoral Knee Jmplant System (K080029), Stryker Corporation's Avon"
Patellofemoral Joint Prosthesis (510k # K010100); Avon" Patellar C Small Patellofemoral Replacement (510k # K041160); and Avon™ PFJ Prosthesis [additional patella components] (510k # K051948).
| Feature | MAKO Surgical Corp. Patellofemoral Knee Implant System II |
|---|---|
| Intended Use/Indications forUse | The MAKO Surgical Corp. Patellofemoral Knee Implant System II is intended to beused in cemented patello-femoral arthroplasty in patients with degenerativearthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibialtubercle 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) usedduring surgery. MPFII can also be used with MAKO Tactile Guidance System(TGS). |
| Sterilization and Packaging | Sterilization:• Patellofemoral and patella components - gamma radiation• Instrumentation - steam sterilizationPackaging:• Both patellofemoral and patella components are supplied in doublesealed containers maintaining double sterile barriers. |
| Biocompatibility | Both devices are made of materials for surgical implant applications perrecognized 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.
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Image /page/1/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, sans-serif font. Above the word "MAKO" is a stylized graphic element that resembles a shark fin or a wave. Below the word "MAKO" is the text "SURGICAL CORP." in a smaller font size. The logo is black and white.
2555 Davie Road ¸ ¸ Et. Lauderdale, FL 33,317 • Phone 954,927,2044 • Fax 954.927,0446 • www.makosurgical.com_
Intended Use/Indications for Use: The MAKO Surgical Corp. Patellofemoral Knee Implant System II 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.
These components are single use only and are intended for implantation with bone cement.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAKO Surgical Corporation % Mr. William F. Tapia Vice President, Regulatory 2555 Davie Road Fort Lauderdale, Florida 33317
OCT 22 2008
Re: K082088
Trade/Device Name: MAKO Surgical Corp. Patellofemoral Knee Implant System II Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis Regulatory Class: II Product Codes: KRR Dated: July 22, 2008 Received: July 24, 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 (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.
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Page 2 - Mr. 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 the reporting 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark N. Wilkerson
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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Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic that resembles a shark fin or a mountain range. The logo is black and white.
2555 Davie Road • Ft, Lauderdale, FL 33317 • Phone 954.927.0446 • Fax 954.927.0446 • www.makosurglcal.com
EXHIBIT G
INDICATIONS FOR USE
510(k) Number (if known):
182088
Device Name: MAKO Surgical Corp. Patellofemoral Knee Implant System II
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 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 General, Restorative,
and Neurological Devices
510(k) Number K082088
§ 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.”