(88 days)
Not Found
No
The document describes a mechanical knee implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is intended for use in treating degenerative joint diseases, correcting deformities, and alleviating pain, which are all therapeutic purposes. Its function as a knee replacement system directly addresses physical conditions in patients.
No
Explanation: The Natural-Knee II Unicompartmental Knee System is described as a medical device for resurfacing a knee joint, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details physical components made of titanium alloy and polymer, intended for surgical implantation. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes tests performed on blood, urine, tissue, etc.
- Device Description: The provided text describes a surgical implant used to replace a portion of the knee joint. It is a physical device implanted into the body to treat a condition (osteoarthritis).
- Intended Use: The intended use clearly states it's for treating unicompartmental knee conditions and is an alternative to total knee replacement. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The device is a Class II or Class III medical device (likely Class III given it's an implant) used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Natural-Knee II Unicompartmental Knee is intended for use in:
- Unicompartmental noninflammatory degenerative joint disease 1. (NIDJD), e.g., avascular necrosis, osteoarthritis and arthritis secondary to a variety of diseases and anomalies;
-
- Passively correctable valqus-varus deformity and moderate flexion contracture;
-
- Those patients with failed previous surgery where pain, deformity or dysfunction persists.
The N-K II Unicompartmental All-Poly Tibia is intended to be used only with bone cement. The modular metal/polymer N-K II Unicompartmental Tibia and Femur are intended for use with or without bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HRY, NJD
Device Description
The Natural-Knee II Unicompartmental Knee System is a conservative, cost-effective alternative to total knee replacement for patients with osteoarthritis primarily confined to one compartment. The N-K II Unicompartmental Knee System is intended for resurfacing of one side of the knee joint.
The N-K II Unicompartmental Modular Metal-backed Tibia is similar to the previously cleared N-K II Unicompartmental Tibia (K955778). The wrought titanium alloy tibial baseplate is a symmetrically designed component, eliminating the need for left/right orientations. The baseplate features three smooth pegs on the underside which aid in positioning and rotational stability. A smooth surface finish is provided on the inner surface of the tibial tray to minimize the potential for polyethylene wear. A screw hole is placed in the center of the baseplate for optional screw fixation. The baseplate is available in either a porous or non-porous version.
The all-poly tibia is designed with a single keel to position the component on the tibia and increase stability. Cement grooves on both the medial and lateral side of the keel increase the anchoring effect of the keel, while a dovetail cement channel around the perimeter of the distal surface, along with a T-pattern dovetail cement channel, act to resist movement in all directions. It is to be used only with bone cement for application directly onto the patient's resected proximal tibia.
The metal-backed and the all-poly tibias are both available in 6 sizes (1-6). The modular metal-backed tibia will be offered in 3 thicknesses (9, 11, and 13 mm). The insert thickness reflects the total amount of bone to be resected. The all-poly insert will be available in 4 thicknesses (7, 9, 11, and 13mm), in which the thickness is measured at the thinnest point from the distal to the proximal surface of the component.
The design of the femoral component of the proposed N-K II Unicompartmental Knee System will not change. This premarket notification only seeks to obtain clearance for the addition of cementless use of the previously cleared porous-coated femur (K955778).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, femorotibial
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.
K955778, K883969, P940002, K012591, K010810, K982859
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.
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510(k) SUMMARY
page 1 of 2
Centerpulse Orthopedics, Inc., a division of Zimmer SPONSOR NAME: 9900 Spectrum Drive Austin, TX 78717
Audrey Swearingen CONTACT: Phone: (512) 432-9255 Audrey Swearingen@Zimmer.com E-Mail:
Natural-Knee® II Unicompartmental Knee System TRADE NAME:
Unicompartmental Knee COMMON NAME:
Unicompartmental Knees are Class II, reviewed by the CLASSIFICATION: Orthopedic Devices panel, per 21 CFR §888.3530 and 888.3535.
PREDICATE DEVICES.
The predicate devices chosen to demonstrate substantial equivalence are:
- Natural-Knee II Unicompartmental Knee System (K955778) .
- Natural-Knee Unicompartmental Knee System (K883969) .
- Natural-Knee II Total Knee System with CSTi (P940002) .
- Wright Medical ADVANCE® Unicompartmental Knee (K012591) .
- DePuy Preservation™ Unicompartmental Knee (K010810) .
- Plus Orthopedics UC Plus™ Unicompartmental Knee (K982859) .
DEVICE DESCRIPTION:
The Natural-Knee II Unicompartmental Knee System is a conservative, cost-effective alternative to total knee replacement for patients with osteoarthritis primarily confined to one compartment. The N-K II Unicompartmental Knee System is intended for resurfacing of one side of the knee joint.
The N-K II Unicompartmental Modular Metal-backed Tibia is similar to the previously cleared N-K II Unicompartmental Tibia (K955778). The wrought titanium alloy tibial baseplate is a symmetrically designed component, eliminating the need for left/right orientations. The baseplate features three smooth pegs on the underside which aid in positioning and rotational stability. A smooth surface finish is provided on the inner surface of the tibial tray to minimize the potential for polyethylene wear. A screw hole is placed in the center of the baseplate for optional screw fixation. The baseplate is available in either a porous or non-porous version.
The all-poly tibia is designed with a single keel to position the component on the tibia and increase stability. Cement grooves on both the medial and lateral side of the keel increase the anchoring effect of the keel, while a dovetail cement channel around the perimeter of the distal surface, along with a T-pattern dovetail cement channel, act to resist movement in all directions. It is to be used only with bone cement for application directly onto the patient's resected proximal tibia.
The metal-backed and the all-poly tibias are both available in 6 sizes (1-6). The modular
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033810
page 2 of 2
000135
metal-backed tibia will be offered in 3 thicknesses (9, 11, and 13 mm). The insert thickness reflects the total amount of bone to be resected. The all-poly insert will be available in 4 thicknesses (7, 9, 11, and 13mm), in which the thickness is measured at the thinnest point from the distal to the proximal surface of the component.
The design of the femoral component of the proposed N-K II Unicompartmental Knee System will not change. This premarket notification only seeks to obtain clearance for the addition of cementless use of the previously cleared porous-coated femur (K955778).
INTENDED USE:
The Natural-Knee II Unicompartmental Knee is intended for use in:
- Unicompartmental noninflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and arthritis secondary to a variety of diseases and anomalies:
- Passively correctable valgus-varus deformity and moderate flexion contracture; 2.
- Those patients with failed previous surgery where pain, deformity or dysfunction ന persists.
These indications for use are identical to the indications for the previously cleared Natural-Knee II Unicompartmental System (K955778) and Natural Knee Unicompartmental System (K883969).
The proposed N-K II Unicompartmental All-Poly Tibia is intended to be used only with bone cement. The N-K II Unicompartmental Modular Tibia and Femur are intended for use with or without bone cement.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Comparisons of device design features, indications for use, materials and labeling of the Natural-Knee II Unicompartmental Knee System demonstrate that it is substantially equivalent to the predicate devices listed above.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three horizontal bars forming the body and wings, and a head facing left. The eagle's tail feathers are depicted as wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
Audrey Swearingen Manager, Regulatory Affairs Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K033810
Trade/Device Name: Natural-Knee® II Unicompartmental Knee System Regulation Numbers: 21 CFR 888.3530 and 21 CFR 888.3535 Regulation Names: Knee joint, femorotibial, metal/polymer semi-constrained cemented Prosthesis, Knee joint, femorotibial (unicompartmental) metal/polymer porous-coated uncemented prosthesis
Regulatory Class: II Product Codes: HRY, NJD Dated: December 5, 2003 Received: December 8, 2003
Dear Ms. Swearingen:
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 10 dcvices 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.
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Page 2 – Ms. Audrey Swearingen
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
William W. Weber, Ph.D., M.D.
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
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Indications for Use
510(k) Number (if known): K033810
Device Name: Natural-Knee® II Unicompartmental Knee System
Indications For Use: The Natural-Knee II Unicompartmental Knee is intended for use in:
- Unicompartmental noninflammatory degenerative joint disease 1. (NIDJD), e.g., avascular necrosis, osteoarthritis and arthritis secondary to a variety of diseases and anomalies;
-
- Passively correctable valqus-varus deformity and moderate flexion contracture;
-
- Those patients with failed previous surgery where pain, deformity or dysfunction persists.
The N-K II Unicompartmental All-Poly Tibia is intended to be used only with bone cement. The modular metal/polymer N-K II Unicompartmental Tibia and Femur are intended for use with or without bone cement.
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, Offically Office Evaluation (ODE)
Wby with
KOR KOR KOR
(Division Sign-Of Division of General. Restorative. and Neurological Devices
Page 1 of
510(k) Number K033810