(50 days)
Not Found
No
The document describes a standard knee implant system and instrumentation, with no mention of AI or ML capabilities.
Yes
The device is a knee implant intended for the reconstruction of damaged knee joints due to conditions like osteoarthritis, which is a therapeutic intervention.
No
Explanation: The device is a surgical implant (unicondylar knee system) and associated instrumentation, used for reconstruction, not for diagnosis.
No
The device description explicitly lists hardware components (femoral component, tibial component, instrumentation) and describes a surgical implant system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for reconstructing a knee joint due to arthritis. This is a therapeutic device used in vivo (within the body).
- Device Description: The components listed (femoral component, tibial component, instrumentation) are all physical implants and surgical tools used during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to be used in vitro (outside the body) to diagnose diseases or conditions.
Therefore, the MAKO Surgical Unicondylar Knee is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MAKO Surgical Unicondylar Knee is a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.
Product codes
87 HSX, HSX
Device Description
The MAKO Surgical Unicondylar Knee System is for use in reconstruction of either the medial or lateral femur and corresponding tibial surface. The MAKO Surgical Unicondylar Knee System consists of the following basic components. These components are intended for cemented, one-time use.
- CoCr distal femoral component .
- UHMWPE tibial resurfacing component -- includes radiographic pin .
Standard unicondylar knee instrumentation is also provided with the system. This includes for example femoral Standard unicondylar knee instrumentation is also provides, this leveling guide, impactor, sizers, femoral templates with handles & peg drill assembly, tibial inotrument trav sizers, femoral templates with handles & peg unlinessentialy, tible in the same of the many of the matrument tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint / medial or lateral femur and corresponding tibial surface
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)
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
FEB 2 3 2006
Image /page/0/Picture/2 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 graphic element that resembles a stylized mountain range or a shark fin, created with a pixelated effect. The overall design is simple and modern, conveying a sense of precision and innovation.
2901 simms street
lei 954 927 2044
fax 954.927.0446
EXHIBIT E - 510(K) SUMMARY
hollywood, florida 33020
| Submitter: | MAKO Surgical Corp. |
|---|---|
| Address: | 2901 Simms Street, Hollywood, FL, 33020 |
| Phone number / Fax Number: | (Ph) 954-927-2044 x105; (F) 954-927-0446 |
| Contact Person: | William F. Tapia |
| Date Prepared: | December 30, 2005 |
| Proprietary Name: | MAKO Surgical Unicondylar Knee System |
| Common Name: | Knee joint femorotibial metal/polymer non-constrained cemented prosthesis |
| 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 Unicondylar Knee System is substantially equivalent to Stelkast Corporation's Unicondylar Knee System (K032824).
| Feature | Stelkast Unicondylar Knee System (K032824) / MAKO Surgical Corp.'s
Unicondylar Knee System |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for
Use | The MAKO Surgical Unicondylar Knee is a single use device intended for
cemented reconstruction of the medial or lateral femur and corresponding tibial
surface of moderately disabled and/or painful knee resulting from osteoarthritis,
traumatic arthritis provided there is evidence of sufficient bone to seat the
implant. Indications for use include moderate joint impairment from painful
arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in
patients with unicompartmental arthritis. |
| Implant Components | CoCr femoral component. UHMWPE tibial component. Radiographic marker pin in tibial component |
| Sizes | Femoral components available in 5 sizes (left and right component for each size). Tibial components available in 5 sizes with 3 thicknesses (6.5mm, 7.5mm, 8.5mm). Thinnest section of 6.5mm tibial component is 6.0mm. |
| Congruency | 20 – 27% congruency |
| Materials | Femoral component – CoCr per ASTM F-75 Tibial component – UHMWPE per ASTM F-648 Type 2. Radiographic marker pin – titanium wire per ASTM F-1341. |
| 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: Implant and tibial components – gamma radiation Instrumentation – prevacuum steam Packaging: Both femoral and tibial components are supplied in double sealed containers maintaining double sterile barriers. Tibial component is packaged in Argon gas environment. |
| Biocompatibility | Both devices are made of materials for surgical implant applications per ASTM
standards listed above. |
Description: The MAKO Surgical Unicondylar Knee System is for use in reconstruction of either the medial or Description. The MANO Ourface. The MAKO Surgical Unicondylar Knee System consists of the following basic components. These components are intended for cemented, one-time use.
- CoCr distal femoral component .
1
Image /page/1/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters. Below the word "MAKO" is the text "SURGICAL CORP" in smaller letters. Above the word "MAKO" is a graphic that resembles a mountain range.
fax 954.327.0446 hollywood, florida 35020 lei 954,927 2044
- UHMWPE tibial resurfacing component -- includes radiographic pin .
2001 simms street
Standard unicondylar knee instrumentation is also provided with the system. This includes for example femoral Standard unicondylar knee instrumentation is also provides, this leveling guide, impactor,
sizers, femoral templates with handles & peg drill assembly, tibial inotrument trav sizers, femoral templates with handles & peg unlinessentialy, tible in the same of the many of the matrument tray.
Intended Use/Indications for Use: The MAKO Surgical Unicondylar Knee is a single use device intended for Intended Uselindications for USE. The MANO Oulgiour Onloondyna mobile in the materaly disabled cemented reconstruction of the medial of lateral leman and sorrosponding tamily in the sudence of sufficient bone to and/or paintil Knee resulting from osteoarinhis, traditions and a thritis (osted and/or postseal the inipiant. Thurcations for asc inolde moderate your the with unicompartmental arthritis.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2006
Mr. William F. Tapia Director of Regulatory/Quality/Clinical Affairs Mako Surgical Corp. 2901 Simms Street Hollywood, California 33020
K060017 Re:
Trade/Device Name: Unicondylar Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Codes: HSX Dated: February 14, 2006 Received: February 15, 2006
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 eoniner to pror of they 2011-11-11 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
3
Page 2 – Mr. William F. Tapia
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CFR Part 807), labeling (21 CFR Part 807), good managed and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 GPD 1960 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declients of Cevice as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your a I his letter will anow you to begin mankeling your antial equivalence of your device to a legally premarket notification. The PDA muding of backand of 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 If you desire specific acries for your 201) 276-0120. Also, please note the regulation entitled, Comact the Office of Comphance at (210) = i Ecation" (21CFR Part 807.97). You may obtain Misolanding Uy Telefone to premailsonibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, international and Oolisanhoon varian of the more of the new online with he
Sincerely yours,
Heckin Leuer (w)
Image /page/3/Picture/5 description: The image shows the name and title of Mark N. Melkerson, M.S., who is the Acting Director of the Division of General, Restorative and Neurological Devices. The image also mentions the Office of Device Evaluation and the Center for Devices and Radiological Health. The text is aligned to the left and is written in a clear, readable font.
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 that resembles a shark fin or a wave. The logo is black and white.
... kr 184 827 0449.... .............................................................................................................................................................................. . . . .......? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . #1 12: #RE #MACC . . . . . .
EXHIBIT G
INDICATIONS FOR USE
510(k) Number (if known): K060017
Device Name: MAKO Surgical Unicondylar Knee System
Indications for Use:
The MAKO Surgical Unicondylar Knee is a single use device intented for cemented reconstruction of the resultiv The MAKO Surgical Unicondyial Khee is a single dse act noc rice neable disabled and/or paintil knee resulting
medial or lateral femur and corresponding tibial surface of mode medial or lateral femur and corresportung tible Sunder disable in the implant.
from osteoarthritis, traumatic arthritis provided there is evidence of seat the implic Indications for use include moderate joint impaiment from painfilis (osteo and/or post-traumatic), and molcations for use include moderate joint impartmental arthrilis.
| Prescription Use | AND/OR | Over-the-Counter Use |
|---|---|---|
| X | ||
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence(Division Sign-Off) Evaluation (ODE)
Division of General, Restorative.
and Neurological Devices
510(k) Number_
the Countor I lea