(255 days)
Not Found
No
The description focuses solely on the mechanical components and materials of the knee system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an orthopedic implant (knee system) designed to restore joint function damaged by various arthritic conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an orthopedic implant (knee system) intended for resurfacing a damaged knee joint, not for diagnosing conditions.
No
The device description clearly outlines physical components made of metallic materials and polyethylene, which are hardware.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a Symmetric Unicompartmental Knee System, which is a surgical implant used to replace a damaged part of the knee joint. It is made of metallic and polyethylene components.
- Intended Use: The intended use is for "restoring either compartment of a knee that has been damaged." This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a device that is implanted into the body for structural support and function, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Symmetric Unicompanimental Knee System is for Cemented Use Only and is indicated for restroing efther compartment of a knee that has been damaged by rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, failed osteotomies or hemiarthroplasties.
Product codes (comma separated list FDA assigned to the subject device)
HRY
Device Description
The Symmetric Unicompartmental Knee System is intended for the resurfacing of one side of the knee joint. The system consists of metallic femoral and tibial components and a polyethylene tibial insert.
The FEMORAL COMPONENT is symmetrically designed eliminating the need for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo) and features a central peg, which aids in stabilization. A central strut is provided for rotational stability and added strength. The femoral component will be available in five sizes (1-5) and will be porous coated with Commercial Pure Titanium (CPTi).
The TIBIAL COMPONENT is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti-6Al-4V). The tibial tray features a central fin and four pegs on the underside aiding in rotational stabilization. A screw hole is in the center of the tibial tray for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 5 sizes (1 - 5) and is porous coated with Commercial Pure Titanium (CPT)).
The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semi-constrained and is captured in the tibial tray by the mating capture features. The insert is available in 5 thicknesses (6, 8, 10, 12, and 14mm) and 5 sizes (1 - 5).
Push-out strength test results on the tibial tray insert are comparable to other legally marketed devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint
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.
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
§ 888.3530 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
K012800
page 1 of 2
| Submitter Name/Address: | Whiteside Biomechanics, Inc.
12634 Olive Blvd.
St. Louis, MO 63141
P: 314-996-8540
F: 314-996-8543 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------|
| Establishment Registration #: | 1932213 |
| Correspondent: | George Palfi |
| Device Name: | Symmetric Unicompartmental Knee System |
| Proprietary Name: | Whiteside Biomechanics, Inc. Symmetric
Unicompartmental Knee System |
| Common Name: | Unicompartmental Knee System |
| Classification Name: | Knee joint femorotibial, metal/polymer, semi-
constrained, cemented prosthesis. |
| Classification Panel: | Class II |
| Substantial Equivalence To: | Natural-Knee II Unicompartmental Knee
(K955778) |
Device Description:
Section 4:
510(k) Summary
The Symmetric Unicompartmental Knee System is intended for the resurfacing of one side of the knee joint. The system consists of metallic femoral and tibial components and a polyethylene tibial insert.
The FEMORAL COMPONENT is symmetrically designed eliminating the need for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo) and features a central peg, which aids in stabilization. A central strut is provided for rotational stability and added strength. The femoral component will be available in five sizes (1-5) and will be porous coated with Commercial Pure Titanium (CPTi).
The TIBIAL COMPONENT is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti-6Al-4V). The tibial tray features a central fin and four pegs on the underside aiding in rotational stabilization. A screw hole is in the center of the tibial
1
1
tray for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 5 sizes (1 - 5) and is porous coated with Commercial Pure Titanium (CPT)).
The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semi-constrained and is captured in the tibial tray by the mating capture features. The insert is available in 5 thicknesses (6, 8, 10, 12, and 14mm) and 5 sizes (1 - 5).
Push-out strength test results on the tibial tray insert are comparable to other legally marketed devices.
The Symmetric Unicompartmental Knee System is also similar to the Howmedica PCA Unicompartmental Knee System, the Johnson & Johnson PFC Unicompartmental Knee System, and the Smith & Nephew Genesis Unicompartmental Knee.
page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Palfi General Manager Whiteside Biomechanics. Inc. 12634 Olive Boulevard St. Louis. Missouri 63141
Re: K012800
Trade/Device Name: Symmetric Unicompartmental Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial, metal/polymer, semi-constrained, cemented prosthesis Regulatory Class: II Product Code: HRY Dated: February 14, 2002 Received: February 15, 2002
Dear Mr. Palfi:
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.
3
Page 2 -- Mr. George Palfi
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Mark N. Millican
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number (if known)t K012800
Device Name: Symmetric Unicompartmental Knee System
Indications For Use:
The Symmetric Unicompanimental Knee System is for Cemented Use Only and is indicated for restroing efther compartment of a knee that has been damaged by rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, failed osteotomies or hemiarthroplasties.
age
(PLEASE DON NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N Miller
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
Ko12800