(129 days)
Not Found
No
The summary describes a mechanical implant system and does not mention any software, image processing, or AI/ML terms.
Yes.
The device is an implantable component for knee arthroplasty, which is a medical procedure to treat painful osteo- or post-traumatic arthritis and revise unsuccessful unicompartmental knee replacements. These are therapeutic indications.
No
The device is a knee implant system used for surgical replacement, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of materials like CoCMo, titanium, and polyethylene, which are implanted into the body. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The provided description clearly states that this device is a surgical implant intended for implantation into the knee joint. It is a physical component used to replace damaged parts of the knee.
- Intended Use: The intended use describes the conditions for which the implant is used (e.g., osteoarthritis, revision surgery) and how it is used (implantation with bone cement). This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
Therefore, based on the provided information, the MAKO Surgical Corp. Unicondylar Knee Implant System II components are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MAKO Surgical Corp. Unicondylar Knee Implant System II 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.
Product codes
87 HSX, HSX
Device Description
This device consists of a CoCMo femoral condyle component, a titanium 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 fenoral 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 insert. The tibial onlay components snap together with an interlocking mechanism. The tibial inlay insert contains a waffle pattern on the bottom side and a peripheral cement channel to enhance fixation when cemented in the tibia.
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)
K033363, K992287, K033769, K020741, K022437, K971938, K060017, K073248
Reference Device(s)
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
K080368 *1/1
JUN 2 0 2008
2555 Davie Road • Ft. Lauderdale, EL 33317 • Phone 954.927.2044 • Fax 954.927.0446 • www.makosurglcal.com
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 15, 2008 |
| Proprietary Name: | MAKO Surgical Corp. Unicondylar Knee Implant System II |
| 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 II is substantially equivalent to Zimmer Unicompartmental Knee System K033363; Stryker ElUS, K992287 & K033769; Encore EPIK Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938; MAKO Surgical Corp. Unicondylar Knee Implant System K060017 & K073248.
| Feature | MAKO Surgical Corp. Unicondylar Knee Implant System II |
|---|---|
| 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 - CoCr 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. | |
| 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 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 fenoral 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 insert. The tibial onlay components snap together with an interlocking mechanism. The tibial inlay insert contains a waffle pattern on the bottom side and a peripheral cement channel to enhance fixation when cemented in the tibia.
Intended Use/Indications for Use: MAKO Surgical Corp. Unicondylar Knee Implant System II 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 osteoarthrifis �
These components are single use only and are intended for implantation with bone cement.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three horizontal lines curving upwards on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2008
MAKO Surgical Corp. % William F. Tapia 2555 Davie Road Ft. Lauderdale, FL 33317
Re: K080368 Trade/Device Name: MAKO Surgical Corp. Unicondylar Knee Implant System II 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: June 16, 2008 Received: June 17, 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.
2
Page 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
MAKO
SURGICAL CORP.
2555 Davie Road . • .Et. Lauderdale, FL 33317 . • Phone 954.927.0446 • www.makosurgical.com
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MAKO Surgical Corp. Unicondylar Knee Implant System II
Indications for Use:
MAKO Surgical Corp. Unicondylar Knee Implant System II 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)
Neil P
Concurrence of CDRH, Office of Device Evaluation (ODE)
for mxm
eral, Restorative, and Neurological Devices
510(k) Number K080368