(84 days)
Not Found
No
The description focuses solely on the physical components and intended use of the knee implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a knee implant system used for unicompartmental knee arthroplasty, which is a surgical procedure to alleviate symptoms and restore function in patients with knee joint disease. This directly addresses and improves a medical condition, qualifying it as a therapeutic device.
No
This device is a knee implant system, which is a prosthetic device used for surgical replacement of knee joint components, not for diagnosing conditions.
No
The device description clearly outlines physical components (femoral condyle, baseplate, tibial onlay, tibial inlay) made of specific materials (CoCMo, titanium alloy, polyethylene) intended for surgical implantation. This is a hardware medical device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant used to replace a portion of the knee joint. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use clearly states it is for "unicompartmental knee arthroplasty" to treat joint disease and revise previous knee replacements. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MAKO Surgical Corp. Unicondylar Knee Implant System III components are for use in unicompartmental knee arthropiasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis
- Revision of previous unsuccessful unicompartmental knee replacement
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
These components are single use only and are intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
87 HSX
Device Description
This device consists of a CoCMo femoral condyle component, a titanium alloy baseplate, and ultra-high molecular weight polyethylene tibial onlay and inlay components have been designed to fit the medial and lateral compartments and are intended for cemented, one-time use only. The femoral condyle component features a polished articular surface, a cement pocket, and 2 fixation pegs. The design of the femoral condyle component allows for up to 155° flexion. The tibial components consist of a tibial onlay (tibial baseplate and tibial onlay insert) and a tibial inlay. The tibial onlay components snap together with an interlocking mechanism. The tibial inlay contains a dovetail channel on the bottom side and a peripheral cement channel to enhance fixation when cemented in the tibia.
The MAKO Surgical Corp. Unicondylar Knee Implant System III is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
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): 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.
K020741, K022437, K080368, K033363
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
§ 888.3520 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
OCT 1 5 2008
Image /page/0/Picture/2 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Below the word "MAKO" is the text "SURGICAL CORP" in a smaller font. Above the word "MAKO" is a stylized black graphic that resembles a mountain range or a stylized letter "M".
2555 Davie Road • Ft. Lauderdale, FL 33317 • Phone 954.927.0446 • Fax 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: | July 22, 2008 |
| Proprietary Name: | MAKO Surgical Corp. Unicondylar Knee Implant System III |
| Common Name: | Unicondylar Knee System |
| Classification Name / #: | Class II; 21 CFR 888.3520 |
| Product Code: | 87 HSX - Knee Joint Femorotibial, Metal/Polymer Non-Constrained, Cemented |
| Prosthesis |
Substantial Equivalence: The MAKO Surgical Corp. Unicondylar Knee Implant System III is substantially equivalent to the Encore EPIK® Uni Knee System (K020741 & K022437), MAKO Surgical Corp. Unicondylar Knee Implant System II (K080368), and the Zimmer Unicompartmental Knee System (ZUK - K033363)
| Feature | MAKO Surgical Corp. Unicondylar Knee Implant System III (MUKSIII) |
|---|---|
| Implant Components | Femoral component Tibial inlay component Radiographic marker in tibial inlay component Tibial onlay insert component Tibial baseplate |
| Sizes | Femoral components are available in 8 sizes. Tibial components are available in 8 sizes |
| Materials | Femoral component - CoCrMo Tibia Inlay component - UHMWPE Radiographic marker in tibial inlay component- Titanium wire Tibia onlay insert component - UHMWPE Tibial Baseplate - Titanium |
| Instrumentation | Provided separately in a re-usable/sterilizable tray. Tray includes various tools |
| (e.g., femoral trials, tibial insert and baseplate trials, impactors, inserters, | |
| extractors) used during surgery. MUKSIII can also be used with MAKO Tactile | |
| Guidance System (TGS). | |
| Sterilization and Packaging | Sterilization: |
| Femoral and tibial components - gamma radiation Instrumentation - steam sterilization Packaging: | |
| Both femoral and tibial 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 CoCMo femoral condyle component, a titanium alloy baseplate, and ultra-high molecular weight polyethylene tibial onlay and inlay components have been designed to fit the medial and lateral compartments and are intended for cemented, one-time use only. The femoral condyle component features a polished articular surface, a cement pocket, and 2 fixation pegs. The design of the femoral condyle component allows for up to 155° flexion. The tibial components consist of a tibial onlay (tibial baseplate and tibial onlay insert) and a tibial inlay. The tibial onlay components snap together with an interlocking mechanism. The tibial inlay contains a dovetail channel on the bottom side and a peripheral cement channel to enhance fixation when cemented in the tibia.
The MAKO Surgical Corp. Unicondylar Knee Implant System III is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
1
MAKO
SURGICAL CORP.
K082081 #d1d
2555 Davie Road • Ft. Lauderdale, FL 33317 • Phone 954.927.2044 • Fax 954.927.0446 • www.makosurgical.com
Indications for Use: MAKO Surgical Corp. Unicondylar Knee Implant System III components are for use in unicompartmental knee arthropiasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis �
- Revision of previous unsuccessful unicompartmental knee replacement �
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis �
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 features a stylized caduceus, which is a symbol of medicine, with a double helix intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2008
MAKO Surgical Corporation % Mr. William F. Tapia VP, Regulatory 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K082081
Trade/Device Name: MAKO Surgical Corporation Unicondylar Knee Implant System III Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: July 22, 2008 Received: July 23, 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
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 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 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 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 a stylized, abstract shape resembling a shark fin or a wave above the word "MAKO" in bold, sans-serif font. Below "MAKO", the words "SURGICAL CORP" are printed in a smaller, sans-serif font.
Phone 954.927.2044 · Fax 954.927.0446 · www.makosurgical.com 2555 Davie Road . Ft. Lauderdale, FL 33317
ATTACHMENT 1
INDICATIONS FOR USE
510(k) Number (K082081):
Device Name: MAKO Surgical Corp. Unicondylar Knee Impiant System III
Indications for Use:
MAKO Surgical Corp. Unicondylar Knee Implant System III components are for use in unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic � arthritis
- Revision of previous unsuccessful unicompartmental knee replacement �
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis �
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mildred for mxm
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510(k) Number K082081