K Number
K063782
Device Name
ACCIN UNI-KNEE SYSTEM
Manufacturer
Date Cleared
2007-01-19

(29 days)

Product Code
Regulation Number
888.3520
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of: Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; Correction of functional deformities: Revision of previous unsuccessful unicompartmental knee replacement or other procedure; As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. These components are single use only and are intended for implantation with bone cement.
Device Description
The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert.
More Information

Not Found

No
The 510(k) summary describes a standard knee implant system and does not mention any AI/ML components or capabilities.

Yes
The device is indicated for treating moderately disabling joint disease of the knee resulting from painful osteoarthritis or post-traumatic arthritis, and for correction of functional deformities. These are conditions that cause suffering and affect human health, and the device aims to alleviate or correct them.

No
The document describes the ACCIN UNI-Knee System as components for unicompartmental knee arthroplasty, which are intended for implantation (replacement parts), not for diagnosing conditions.

No

The device description explicitly states it consists of physical components (Cobalt Chrome femoral component, tibial tray, and polyethylene tibial insert), which are hardware.

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 treating knee joint disease. This is a therapeutic device, not a diagnostic one.
  • Device Description: The device components (femoral component, tibial tray, tibial insert) are all physical implants designed to replace parts of the knee joint. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.

Therefore, the ACCIN UNI-Knee System is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of:

  • Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
  • Correction of functional deformities;
  • Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
  • As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

These components are single use only and are intended for implantation with bone cement.

Product codes

HSX

Device Description

The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert. The Accin UNI-Knee additional tibia bearing components are equivalent to the currently marketed Accin UNI-Knee tibia bearing components with the exception of thickness. The Accin UNI-Knee additional tibia bearing components will make the bearing thickness range (8mm to 14mm) equivalent to that of the currently marketed Zimmer Unicompartmental Knee System.

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Accin UNI-Knee System - K060670, Zimmer Unicompartmental Knee System - K033363

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.

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K06 3782 Page 1/2

JAN 1 9 2007

ACCIN UNI-Knee System Line Extension Premarket Notification Submission - Special 510(k)

Summary of Safety and Effectiveness

| Submitter: | Michael Kvitnitsky
ACCIN Corporation
1033 US Highway 46, Suite A204
Clifton, NJ 07103 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 19, 2006 |
| Device: | ACCIN UNI-Knee System |
| Classification: | 87 HSX - Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal
Polymer, 21 CFR 888.3520, Class II |
| Predicate Device: | Accin UNI-Knee System - K060670
Zimmer Unicompartmental Knee System - K033363 |
| Device Description: | The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and
tibial tray and a polyethylene tibial insert. |
| Intended Use: | The ACCIN UNI-Knee System components are for use in Unicompartmental knee
arthroplasty as a result of:
Moderately disabling joint disease of the knee resulting from painful osteoarthritis
or post traumatic arthritis; |

  • l Correction of functional deformities:
  • Revision of previous unsuccessful unicompartmental knee replacement or other l procedure;
  • r As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

These components are single use only and are intended for implantation with bone cement.

Comparison to Predicates:

The ACCIN UNI-Knee system consists of cobalt chrome femoral and tibial components and a polyethylene insert. The Accin UNI-Knee additional tibia bearing components are equivalent to the currently marketed Accin UNI-Knee tibia bearing components with the exception of thickness. The Accin UNI-Knee additional tibia bearing components will make the bearing thickness range (8mm to 14mm) equivalent to that of the currently marketed Zimmer Unicompartmental Knee System.

Description of Device Modification:

This submission is intended to address a line extension of the Accin UNI-Knee system. The line extension includes additional tibia bearing components 11mm, 13mm and 14mm, making the tibia bearing thickness range 8mm to 14mm, in 1mm increments. No other changes or additions are being made.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2007

Accin Corporation % Mr. Michael Kvitnitsky President 1033 US Highway 46 East Suite A204 Clifton, New Jersey 07103

Re: K063782

Trade/Device Name: ACCIN UNI-Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: December 19, 2006 Received: December 26, 2006

Dear Mr. Kvitnitsky:

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.

2

Page 2 - Mr. Michael Kvitnitsky

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. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buell
TN

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Indications for Use Form

510(k) Number (if known): _ _ _ _ _ _ _

Device Name: ACCIN UNI-Knee System

Indications for Use:

Indications for Use:

The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of:

  • Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post . traumatic arthritis;
  • Correction of functional deformities; .
  • Revision of previous unsuccessful unicompartmental knee replacement or other . procedure;
  • As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. .

These components are single use only and are intended for implantation with bone cement.

Prescription Use __ X (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aarbaue Breur
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K063782

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