K Number
K973406
Device Name
OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT
Manufacturer
Date Cleared
1997-12-08

(90 days)

Product Code
Regulation Number
888.3560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation. The indications for use are: - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis, complicated by the presence of bone loss. - . Post-traumatic loss of knee joint configuration and function. - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability. - Revision of previous unsuccessful knee replacement or other procedure, accompanied by . bone loss. - Ligamentous instability requiring implant bearing surface geometries with increased . constraint. - Absent or non-functioning posterior cruciate ligament. .
Device Description
The Osteonics® Series 7000 Total Knee Augmented Femoral Component features a posterior stabilizing housing, intercondylar cam, fixed intramedullary stem, waffled interior surface pattern, optional nitrogen ion implanted bearing surface treatment (LFIT™), and a distal and posterior build-up on the interior of the component to compensate for femoral bone loss.
More Information

Not Found

Not Found

No
The summary describes a mechanical implant with no mention of software, algorithms, or data processing that would indicate AI/ML.

Yes
The device is described as replacing the articulating surface of the distal femur in a total knee arthroplasty to treat painful, disabling joint disease. This explicitly indicates its therapeutic purpose.

No

Explanation: The device is described as an "Augmented Femoral Component" intended to replace the articulating surface of the distal femur in a total knee arthroplasty, and it is a "single use component intended for cemented fixation." Its indications for use are related to treating painful joint disease and post-traumatic conditions, not diagnosing them.

No

The device description clearly indicates it is a physical implant (femoral component) made of materials and featuring physical characteristics like a posterior stabilizing housing, intercondylar cam, and intramedullary stem. 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 used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
  • Device Description and Intended Use: The provided text clearly describes a surgical implant intended to be placed inside the body to replace a part of the knee joint. It is a physical component used in a surgical procedure.

The information provided about the device's function, indications for use, and description all point to it being a surgical implant, not an IVD.

N/A

Intended Use / Indications for Use

The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation. The indications for use are:

  • Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis, complicated by the presence of bone loss.
  • . Post-traumatic loss of knee joint configuration and function.
  • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
  • Revision of previous unsuccessful knee replacement or other procedure, accompanied by . bone loss.
  • Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
  • Absent or non-functioning posterior cruciate ligament. .

Product codes (comma separated list FDA assigned to the subject device)

HEX

Device Description

The Osteonics® Series 7000 Total Knee Augmented Femoral Component features a posterior stabilizing housing, intercondylar cam, fixed intramedullary stem, waffled interior surface pattern, optional nitrogen ion implanted bearing surface treatment (LFIT™), and a distal and posterior build-up on the interior of the component to compensate for femoral bone loss.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

distal femur, 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)

Applicable performance testing demonstrates that no significant difference exists between this component and the predicate designs.

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.

Not Found

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

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.

0

K973406

Osteonics" Series 7000 Total Knee Augmented Femoral Component

510(k) Premarket Notification

510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS

DEC - 8 1997

OSTEONICS® SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT

Submission Information Name and Address of the Sponsor of the 510(k) Submission:

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900

Regulatory Affairs Specialist

Contact Person:

Date Summary Prepared:

Device Identification Proprietary Name:

Common Name:

Classification Name and Reference:

September 8, 1997

Donna S. Wilson

Osteonics® Series 7000 Total Knee Augmented Femoral Component

Knee Prosthesis

Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis; 21 CFR §888.3560

Predicate Device Identification

The Osteonics® Series 7000 Total Knee Augmented Femoral Component is substantially equivalent to the Osteonics® Series 7000 Total Knee Posteriorly Stabilized Long Stem Femoral Component.

Device Description

The Osteonics® Series 7000 Total Knee Augmented Femoral Component features a posterior stabilizing housing, intercondylar cam, fixed intramedullary stem, waffled interior surface pattern, optional nitrogen ion implanted bearing surface treatment (LFIT™), and a distal and posterior build-up on the interior of the component to compensate for femoral bone loss.

1

Intended Use

The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation.

Statement of Technological Comparison

The Osteonics® Series 7000 Total Knee Augmented Femoral Component shares the same materials, indications and intended use, and basic design features of the predicate devices. Applicable performance testing demonstrates that no significant difference exists between this component and the predicate designs.

2

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

DEC 8 1997

Ms. Donna S. Wilson Requlatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K973406 Re : Osteonics Series 7000 Total Knee Augmented Femoral Component Requlatory Class: II Product Code: ਹੈਕਸ September 8, 1997 Dated: Received: September 9, 1997

Dear Ms. Wilson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

    1. This device may not be labeled or promoted for noncemented use.
    1. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
    1. Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) requlation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.

3

Page 2 - Ms. Donna S. Wilson

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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" (21 CFR 807.97). Other genera Other general information on your responsibilities under the Act may be

4

Page 3 - Ms. Donna S. Wilson

obtained from the Division of Small Manufacturers Assistance obtained from the Division of Small March (301) 443-6597 or at
at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its toll-free number (600) 656-2041 Of (600) do 100 homemain.itml".
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

5

510(k) Number (if known): K973406

Device Name: Osteonics® Series 7000 Total Knee Augmented Femoral Component

Intended Use:

The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation. The indications for use are:

  • Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis, complicated by the presence of bone loss.
  • . Post-traumatic loss of knee joint configuration and function.
  • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
  • Revision of previous unsuccessful knee replacement or other procedure, accompanied by . bone loss.
  • Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
  • Absent or non-functioning posterior cruciate ligament. .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) NumberK973406
Prescription Use (Per 21 CFR 801.109)X
OR
Over-The-Counter Use_

(Optional Format 1-2-96)