(124 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a knee implant, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a knee arthroplasty system intended to treat conditions like degenerative joint disease and correct functional deformities, which are therapeutic interventions.
No
This device is a unicondylar knee system used for knee arthroplasty, which is a surgical treatment, not a diagnostic procedure. Its purpose is to replace or repair knee joints, not to identify or characterize diseases.
No
The device description clearly lists multiple hardware components made of various materials (Cobalt Chrome Alloy, UHMWPE, Titanium Alloy) and describes mechanical testing performed on these physical components.
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 knee arthroplasty to treat conditions like osteoarthritis and deformities. This is a therapeutic device implanted within the body.
- Device Description: The device description details the materials and components of a knee implant (femoral components, tibial inserts, tibial bases). These are physical parts designed to replace or augment a joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implantable medical device used within the body for treatment.
N/A
Intended Use / Indications for Use
The EVOLUTION™ Unicondylar Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
-
- correction of functional deformity;
- revision procedures where other treatments or devices have failed: and treatment of fractures 3. that are unmanageable using other techniques.
The EVOLUTION™ Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The EVOLUTION™ Unicondylar Knee System is for cemented use only.
Product codes
HRY, HSX
Device Description
The design features of the EVOLUTION™ Unicondylar Knee System are summarized below:
- . Femoral components manufactured from Cobalt Chrome Alloy
- Femoral component sizes 1 5, Resurfacing- or Resection-based .
- . Tibial inserts manufactured from UHMWPE
- . Tibial insert: Universal, sizes 1 - 5
- Tibial insert: Conforming, sizes 1 5, left and right .
- . Tibial component thickness: 8, 9, 10, 11, 12mm
- . Tibial bases manufactured from Titanium Alloy
- Tibial base sizes 1 – 5, left and right
- . All-poly tibial components manufactured from UHMWPE
- . All-poly Universal: sizes 1 - 5, left and right
- . All-poly Conforming: sizes 1 - 5, left and right
- . All-poly tibial component thickness: 7, 8, 9, 10, 11, 12mm
The EVOLUTION™ Unicondylar Knee System was evaluated via mechanical testing and engineering analyses; including static stability, contact area, lock detail, femoral component strength, range of motion, and wear testing. A review of these results indicates that the EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
skeletally mature patients
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 EVOLUTION™ Unicondylar Knee System was evaluated via mechanical testing and engineering analyses; including static stability, contact area, lock detail, femoral component strength, range of motion, and wear testing. A review of these results indicates that the EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K881779, K012591, K014171, K030193, K972770, K093552
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented 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 surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
AUG 1 0 2010
510(K) Summary of Safety and Effectiveness
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLUTION™ Unicondylar Knee System.
| Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd, Arlington TN, 38002
(800) 238-7188 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 2, 2010 |
| Contact Person: | Danielle Mueller
Regulatory Affairs Specialist II |
| Proprietary Name: | EVOLUTION™ Unicondylar Knee System |
| Common Name: | Unicondylar Knee System |
| Classification Name and Reference: | 21 CFR 888.3530 Knee joint Femorotibial
Metal/Polymer Semi-Constrained Cemented
Prosthesis Class II
21 CFR 888.3520 Knee joint Femorotibial
Metal/Polymer Non-Constrained Cemented
Prosthesis Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/ HRY, HSX |
| Predicate Devices: | ADVANTIM® Unicondylar Knee System
ADVANCE® Unicondylar Knee System
ADVANCE® Ultra-Congruent Tibial Insert
EVOLUTION™ MP Total Knee System
510(k)s: K881779, K012591, K014171, K030193,
K972770, K093552 |
DEVICE INFORMATION#### A. Intended Use
The EVOLUTION™ Unicondylar Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
-
- correction of functional deformity;
... . . . . .
- revision procedures where other treatments or devices have failed: and treatment of fractures 3. that are unmanageable using other techniques.
1
The EVOLUTION™ Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The EVOLUTION™ Unicondylar Knee System is for cemented use only.
B. Device Description
The design features of the EVOLUTION™ Unicondylar Knee System are summarized below:
- . Femoral components manufactured from Cobalt Chrome Alloy
- Femoral component sizes 1 5, Resurfacing- or Resection-based .
- . Tibial inserts manufactured from UHMWPE
- . Tibial insert: Universal, sizes 1 - 5
- Tibial insert: Conforming, sizes 1 5, left and right .
- . Tibial component thickness: 8, 9, 10, 11, 12mm
- . Tibial bases manufactured from Titanium Alloy
- Tibial base sizes 1 – 5, left and right
- . All-poly tibial components manufactured from UHMWPE
- . All-poly Universal: sizes 1 - 5, left and right
- . All-poly Conforming: sizes 1 - 5, left and right
- . All-poly tibial component thickness: 7, 8, 9, 10, 11, 12mm
The EVOLUTION™ Unicondylar Knee System was evaluated via mechanical testing and engineering analyses; including static stability, contact area, lock detail, femoral component strength, range of motion, and wear testing. A review of these results indicates that the EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
C. Substantial Equivalence Information
The indications for use of the EVOLUTION™ Unicondylar Knee System are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the EVOLUTION™ Unicondylar Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technologies, Inc. % Ms. Danielle Mueller Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Allo 1 0 2010
Re: K100973
Trade/Device Name: EVOLUTION Unicondylar Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY, HSX Dated: July 15, 2010 Received: July 16, 2010
Dear Ms. Mueller:
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. Iisting 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Danielle Mueller
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Clabare Buchus
Mark N. Melker Son Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K100973
Indications for Use
510(k) Number (if known):
AUG 1 0 2010
Device Name: EVOLUTION™ Unicondylar Knee System
Indications For Use:
The EVOLUTION™ Unicondylar Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
- noninflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed: and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION™ Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The EVOLUTION™ Unicondylar Knee System is for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
Sonuta for mxm
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Surgical, Orthopedic, ivision o and Restorative Devices
510(k) Number K100973