(119 days)
Not Found
No
The summary describes a knee implant system and its intended use with a "Tactile Guidance System," but there is no mention of AI, ML, image processing, or any data related to training or testing of algorithms. The focus is on the mechanical components and their application.
Yes
The device is a knee implant system intended for replacement in individuals with osteoarthritis or post-traumatic arthritis, which is a therapeutic intervention.
No
Explanation: The device is an implant system used for knee replacement, not for diagnosing medical conditions. It is used in conjunction with a guidance system, but the implant itself does not perform diagnostic functions.
No
The device description clearly states it is an "implant system" composed of physical components (MMKC-Uni and MMKC-PF) intended for surgical implantation. It also mentions being used in conjunction with the MAKO Tactile Guidance System, which is a robotic arm system, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant system used for knee replacement. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use is for "single or multi-compartmental knee replacement," which is a surgical procedure, not a diagnostic test performed on samples.
Therefore, based on the description and intended use, the MAKO Modular Knee Compartmental Implant System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral and/or patellofemoral articular surfaces.
The MAKO Modular Knee Compartmental Implant System is for single use only and is intended for implantation with bone cement.
Product codes
KRR, HSX, NPJ, HRY
Device Description
The MMKC is composed of a unicompartmental implant system (MMKC-Uni) and a PF implant system (MMKC-PF). MMKC-Uni and MMKC-PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. MMKC-UNI is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Implant Components:
MMKC-Uni
Femoral component
Tibial inlay component
Radiographic marker in tibial inlay component
Tibial onlay insert component
Tibial baseplate
MMKC-PF
Patellofemoral component
Patella component
Sizes:
MMKC-Uni
Femoral components are available in 8 sizes. Tibial components are available in 8 sizes.
MMKC-PF
Patellofemoral components available in 8 sizes. The patella components are available in 6 sizes.
Materials:
MMKC-Uni
Femoral component - CoCr
Tibia Inlay component - UHMWPE
Radiographic marker in tibial inlay component- Titanium wire
Tibia onlay insert component - UHMWPE
Tibial Baseplate - Ti6Al4V
MMKC-PF
Patellofemoral component - CoCr
Patella component - UHMWPE
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. MMKC, MMKC-Uni, MMKC-PF can only be used with the MAKO Tactile Guidance System (TGS).
Sterilization and Packaging:
Sterilization:
• All components - gamma radiation
• Instrumentation - steam sterilization
Packaging:
• All components are supplied in double sealed containers maintaining double sterile barriers.
Biocompatibility:
All components are made of materials for surgical implant applications per recognized ASTM standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080029, K080368, K052917, K061648, K070849
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, sans-serif font. Below the word "MAKO" is the text "SURGICAL CORP" in a smaller font size. Above the word "MAKO" is a stylized graphic element that resembles a shark fin or a mountain peak.
NOV 28 2008
2555 Davie Road • Ft. Lauderdale, FL 33317 • Phone 954.927.0446 • www.makosurgical.com..
ATTACHMENT 3 - 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 30, 2008 |
| Proprietary Name: | MAKO Surgical Corp. Compartmental Knee Implant System (MMKC) |
| Common Name: | Compartmental Knee Prosthesis System |
| Classification: | Class II |
| Product Code / #: | KRR - Knee joint patellofemoral polymer/metal semi-constrained cemented |
| prosthesis; 21 CFR 888.3540 | |
| HSX - Knee joint femorotibial metal/polymer non-constrained cemented | |
| prosthesis; 21 CFR 888.3520 | |
| NPJ - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained | |
| cemented prosthesis; 21 CFR 888.3560 | |
| HRY - Knee joint femorotibial metal/polymer semi-constrained cemented | |
| prosthesis: 21 CFR 888.3530 |
Description: The MMKC is composed of a unicompartmental implant system (MMKC-Uni) and a PF implant system (MMKC-PF). MMKC-Uni and MMKC-PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. MMKC-UNI is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
| Feature | MAKO Surgical Corp. Compartmental Knee Implant System (MMKC) |
|---|---|
| Implant Components | MMKC-Uni Femoral component Tibial inlay component Radiographic marker in tibial inlay component Tibial onlay insert component Tibial baseplate MMKC-PF Patellofemoral component Patella component |
| Sizes | MMKC-Uni Femoral components are available in 8 sizes. Tibial components are available in 8 sizes. MMKC-PF Patellofemoral components available in 8 sizes. The patella components are available in 6 sizes. |
| Materials | MMKC-Uni Femoral component - CoCr Tibia Inlay component - UHMWPE Radiographic marker in tibial inlay component- Titanium wire Tibia onlay insert component - UHMWPE Tibial Baseplate - Ti6Al4V MMKC-PF Patellofemoral component - CoCr Patella component - UHMWPE |
| 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. MMKC, MMKC-Uni, MMKC-PF can only be used with the MAKO | |
| Tactile Guidance System (TGS) |
1 - 1 - 1 - 1
1
Image /page/1/Picture/0 description: The image contains handwritten text that appears to be a combination of letters and symbols. The text includes the sequence "KOBADA" followed by a symbol resembling a hashtag and the characters "d/2". The handwriting is somewhat stylized, with some letters connected and others distinct, giving the text a unique visual appearance.
Image /page/1/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic element that resembles a shark fin or a stylized mountain peak.
2555 Davie Road . • Ft. Lauderdale, FL 33317 . • Phone 954.927.0446 • www.makosurgical.com..
| Sterilization and Packaging | Sterilization:
• All components - gamma radiation
• Instrumentation - steam sterilization
Packaging:
• All components are supplied in double sealed containers maintaining double
sterile barriers. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | All components are made of materials for surgical implant applications per
recognized ASTM standards. |
Substantial Equivalence: The MAKO Surgical Corp. Compartmental Knee Implant System is substantially equivalent to MAKO Surgical Corp.'s Patellofemoral Knee Implant System (K080029); MAKO Surgical Corp.'s Unicondylar Knee Implant System II (K080368); Stryker® Compartmental Knee System (K052917); Depuy Graduated Compartmental Knee (K061648) and DePuy GCK Femoral and Tibial Components (K070849)
Indications for Use:
The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral and/or patellofemoral articular surfaces.
The MAKO Modular Knee Compartmental Implant System is for single use only and is 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 stylized eagle-like symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
NOV 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAKO Surgical Corp. % Mr. William F. Tapia Vice President, Regulatory 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K082172
Trade/Device Name: MAKO Modular Knee Compartmental Implant System (MMKC) Regulation Number: 21 CFR 888.3560 Regulation Name: Knec joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: NPJ, KRR, IISX, HRY Dated: November 18, 2008 Received: November 19, 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 cither 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
3
Page 2 - Mr. William F. Tapia
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,
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 logally marketed predicate device results in a classification for your device and thus, permitts 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 Compulario 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 Pestmarket 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millerson
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 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 element that resembles a shark fin or a mountain peak. The logo is black and white.
2555 Davie Road · Et. Lauderdale, FL 33317 · Phone 954.927.0446 · www.makosurgical.com_
ATTACHMENT 2
INDICATIONS FOR USE
510(k) Number (if known): K082172
Device Name: MAKO Modular Knee Compartmental Implant System (MMKC)
Indications for Use:
The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral articular sufaces.
The MAKO Modular Knee Compartmental Implant System is for single use only and is intended for implantation with bone cement.
X 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. . . . .
. '
Mark A. Melhers
.
.
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
. . . .