(204 days)
Not Found
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a knee system intended to treat painful osteo- or post-traumatic arthritis and revise unsuccessful surgical procedures to alleviate pain and restore joint function, which are considered therapeutic actions.
No
The device is a knee implant system intended for unicompartmental knee arthroplasty, not for diagnosing medical conditions. Its purpose is to treat conditions like arthritis by replacing parts of the knee joint.
No
The device description clearly states it is a "unocompartmental knee system that includes porous coated, cast CoCr, asymmetric femoral components... and Ti6Al4V, asymmetric, porous tibial baseplate components". These are physical hardware components, not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant intended for unicompartmental knee arthroplasty. It is a physical device implanted into the body to replace damaged parts of the knee joint.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is to restore function and alleviate pain in a damaged knee joint.
Therefore, based on the provided information, the Restoris® Porous Partial Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:
- . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
- . As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
The Restoris® Porous Femoral Component and PST Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application.
Product codes (comma separated list FDA assigned to the subject device)
HRY, NJD
Device Description
The Restoris® Porous Partial Knee System is a unicompartmental knee system that includes porous coated, cast CoCr, asymmetric femoral components in sizes 1 – 8; and Ti6Al4V, asymmetric, porous tibial baseplate components in sizes 1 - 8. The subject femoral and tibial baseplate components are compatible and are intended for use with predicate MAKO Restoris MCK Tibial Onlay Inserts in standard UHMWPE or highly crosslinked vitamin E UHMWPE (K090763, K133039). The sagittal articular surface of the femoral condyle has an extended posterior radius that accommodates flexion up to 155%.
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)
The Restoris® Porous Partial Knee System has been evaluated, either by new testing and analysis submitted in this 510(k) for femoral component fatigue, tibial baseplate fatigue, and porous surface characterization, or by testing previously submitted in predicate 510(k) #K090763 or #K133039 for the tibial insert/baseplate locking mechanism strength, femorotibial conguency, femorotibial contact area, and range of motion. The testing demonstrates that the Restoris® Porous Partial Knee System when used as intended with the predicate MAKO Restoris MCK Tibial Onlay Inserts, is capable of withstanding expected in vivo loading and is substantially equivalent to predicate knee systems.
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.
K090763, K082172, K033810, K112802
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
§ 888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surface. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra-high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial baseplate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
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Restoris® Porous Partial Knee System 510(k) Summary
JUL 0882014
| Device Proprietary Name: | Restoris Porous Partial Knee System |
|---|---|
| Common Name: | Artificial Partial Knee System |
| Classification regulation: | 888.3530 (Knee joint femorotibial metal/polymer |
| semi-constrained cemented prosthesis) and | |
| 888.3535 (Knee joint femorotibial (uni- | |
| compartmental) metal/polymer porous-coated | |
| uncemented prosthesis) | |
| Device Class: | Class II |
| Product Codes: | HRY and NJD |
| Submitter's Name: | MAKO Surgical Corp. |
| Address: | 2555 Davie Road |
| Fort Lauderdale, FL 33317 | |
| Contact Person: | Robert C. Cohen |
| Telephone Number: | (973) 267-8800 |
| Fax Number: | (973) 267-8810 |
| Date Summary Prepared: | December 13, 2013 |
Device Description:
The Restoris® Porous Partial Knee System is a unicompartmental knee system that includes porous coated, cast CoCr, asymmetric femoral components in sizes 1 – 8; and Ti6Al4V, asymmetric, porous tibial baseplate components in sizes 1 - 8. The subject femoral and tibial baseplate components are compatible and are intended for use with predicate MAKO Restoris MCK Tibial Onlay Inserts in standard UHMWPE or highly crosslinked vitamin E UHMWPE (K090763, K133039). The sagittal articular surface of the femoral condyle has an extended posterior radius that accommodates flexion up to 155%.
Intended Use
Restoris® Porous Partial Knee System components are The intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:
- . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of an unicompartmental knee prosthesis.
1
Restoris® Porous Partial Knee System 510(k) Summary
- As an alternative to tibial osteotomy in patients with unicompartmental . osteoarthritis.
The Restoris® Porous Femoral Component and PST Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application.
Predicate Devices:
Restoris® Porous Partial Knee System is similar to the following predicates:
| Trade/Proprietary Name | Manufacturer | 510(K) # | Clearance Date |
|---|---|---|---|
| Restoris MCK Knee System | MAKO Surgical | K090763 | 6/17/2009 |
| MMCK Uni Knee System | MAKO Surgical | K082172 | 11/28/2008 |
| Natural-Knee® II Unicompartmental | |||
| Knee System | CenterPulse | ||
| Orthopedics/Zimmer | K033810 | 3/5/2004 | |
| MAKO Restoris® Hip System | |||
| (Pipeline Total Hip System) | MAKO (Pipeline | ||
| Orthopedics acquired | |||
| by MAKO) | K112802 | 03/12/2012 |
Purpose of Submission:
The 510(k) submission is for new unicompartmental knee system femoral and tibial tray . components.
Technological Characteristics:
The Restoris® Porous Partial Knee System has the same indications for use, design features, and materials as one or more of the identified predicate knee systems. The porous surface of the subject Restoris® Porous Partial Knee System tibial baseplates is the same as the porous surface of the predicate MAKO Restoris® Total Hip System (K112802) acetabular shells.
Performance Testing:
The Restoris® Porous Partial Knee System has been evaluated, either by new testing and analysis submitted in this 510(k) for femoral component fatigue, tibial baseplate fatigue, and porous surface characterization, or by testing previously submitted in predicate 510(k) #K090763 or #K133039 for the tibial insert/baseplate locking mechanism strength, femorotibial conguency, femorotibial contact area, and range of motion. The testing demonstrates that the Restoris® Porous Partial Knee System when used as intended with the predicate MAKO Restoris MCK Tibial Onlay Inserts, is capable of withstanding expected in vivo loading and is substantially equivalent to predicate knee systems.
2
Restoris® Porous Partial Knee System 510(k) Summary
Conclusions:
The Restoris® Porous Partial Knee System has the same indications for use, is manufactured from the same materials, and has similar design features as compared with one or more of the predicate knee systems. Characterization of the device porous surfaces has shown them equivalent to predicate device porous coatings. Engineering analyses and mechanical testing demonstrate that the performance characteristics of the Restoris® Porous Partial Knee System are equivalent to those of other legally marketed knee systems. Therefore, the Substantial Equivalence of the subject device for the proposed indications for use is demonstrated.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo with the words "HUMAN SERVICES - USA" arranged in a circular pattern around a symbol. The symbol is a stylized depiction of an eagle or bird in flight, with its wings spread and feathers suggested by curved lines. The logo appears to be a government or organizational emblem, possibly related to health or social services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2014
MAKO Surgical Corp. % Ms. Terry Sheridan Powell Consultant M Squared Associates, Inc. 575 Eighth Avenue Suite 1212 New York, New York 10018
Re: K133811
Trade/Device Name: Restoris Porous Partial Knee System Regulation Number: 21 CFR 888.3535 Regulation Name: Knee joint femorotibial (uni-compartmental) metal/polymer porouscoated uncemented prosthesis
Class: Class II Product Code: NJD, HRY Dated: May 23, 2014 Received: May 27, 2014
Dear Ms. Powell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Terry Sheridan Powell
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiaains
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K133811 510(k) Number: To be assigned -
Device Name: Restoris® Porous Partial Knee System
Indications for Use:
The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:
- . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
- . As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
The Restoris® Porous Femoral Component and PST Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application.
AND/OR -Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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