The Duracon® CS (Condylar Stabilizing) Lipped Extra Small Tibial Insert is intended to be used with Duracon® Extra Small Universal and Cruciform tibial baseplates, Duracon® Cruciate Retaining femoral components and Duracon® patellar components as part of a total knee system in primary cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments should be intact if this insert is utilized. This tibial insert may also be used in situations where the posterior cruciate ligament is present - its geometry will accommodate that ligament. More specific indications and contraindications are listed below:

Indications

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,
Rheumatoid arthritis,
Correction of functional deformity,
Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
Irreparable fracture of the knee

Contraindications

Absolute contraindications include:

Overt infection.
Distant foci of infections (which may cause hematogenous spread to the implant site),
Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram,
Skeletally immature patients
Cases where there is poor bone stock which would make the procedure unjustifiable,

Conditions presenting an increased risk of failure include:

Uncooperative patient or patient with neurological disorders who is incapable of following instructions.
Osteoporosis,
Metabolic disorders which may impair bone formation,
Osteomalacia, and
Previous arthrodesis

Device Description

The subject Duracon® Extra Small CS Lipped Tibial Insert is an ultra-high molecular weight polyethylene tibial insert designed to be used with the femoral, tibial, and patellar components of the Duracon® Total Knee System. This insert is available in an extrasmall size in the following thicknesses: 9mm, 11mm, 13mm, and 16mm. The subject insert has a dished articulating surface geometry to provide anatomic rollback, flexionextension and internal-external rotation. The subject tibial insert features a raised anterior eminence designed to provide greater anterior constraint in situations where the posterior cruciate ligament is not present or not functional. This anterior eminence is designed to provide substitution for the posterior cruciate ligament if it is not present or cannot be preserved.

The subject insert does not feature a support post. This allows the Duracon® CS Lipped Extra Small Tibial Insert to be used with the Duracon® Condylar Femoral Components. These condylar femoral components do not require the removal of additional bone from the distal surface of the femur. Because this insert does not feature a support post, it may also be used in situations where the posterior cruciate ligament is present. The geometry of the insert will accommodate the PCL if it is present.

The subject Duracon® CS Lipped Extra Small Tibial Insert features the same locking mechanism as the previously released Duracon® Condylar and AP Lipped Tibial Insert.

Engineering analyses were presented to characterize the function of the subject tibial insert, and to demonstrate substantial equivalence to other legally marketed devices.

AI/ML Overview

The provided document describes a medical device, the Duracon® CS Lipped Extra Small Tibial Insert, which is a component of a total knee arthroplasty system. It is a 510(k) premarket notification for this device.

However, the document does not contain information regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy, etc.), or details of any studies (like clinical trials, standalone algorithm performance studies, or MRMC studies) that would typically be conducted for AI/software-as-a-medical-device (SaMD).

Instead, this document focuses on:

Device Identification: Proprietary name, common name, classification, and product code.
Intended Use: Specific types of patients and conditions for which the device is designed.
Indications for Use: Detailed medical conditions the device addresses.
Contraindications: Conditions under which the device should not be used.
Device Description: Physical characteristics and design features (e.g., ultra-high molecular weight polyethylene, dished articulating surface, raised anterior eminence, locking mechanism).
Substantial Equivalence Claim: The primary basis for 510(k) clearance, stating that engineering analyses were presented to characterize the function and demonstrate substantial equivalence to other legally marketed devices. This implies comparison to existing, already cleared knee replacement components, rather than a novel AI system.
FDA Clearance Letter: Confirmation from the FDA that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance" or information regarding "the study that proves the device meets the acceptance criteria" because this type of information is not present in the provided text for this specific device.

The questions you've asked (about sample sizes, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, and training sets) are highly relevant to AI/SaMD submissions, which often involve extensive performance testing and clinical validation. This document, however, is for a physical orthopedic implant and does not describe such studies. The "engineering analyses" mentioned likely refer to biomechanical testing, wear testing, and material characterization to ensure the physical properties and mechanical performance of the implant are safe and effective and comparable to existing devices.

Summary

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510(k)Premarket Notification

K023724

II
page 1 of 3

2003

	510(k) Summary	FEB 03
Submission Information
Name and Address of Sponsor:	Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401
For Information contact:	Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401
Device Identification
Proprietary Name:	Duracon® CS Lipped Extra Small Tibial Insert
Common Name:	Polyethylene Tibial Insert
Classification Name and Reference:	Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR §888.3560
Proposed Regulatory Class:	Class II
Device Product Code:	OR(87) JWH Prosthesis, Knee Patellofemorotibial, Semi- Constrained, Cemented, Polymer/Metal/ Polymer

Duracon® CS Lipped Extra Small Tibial Insert

Confidential

{1}------------------------------------------------

page 2 of 3

insert is utilized. This tibial insert may also be used in situations where the posterior cruciate ligament is present - its geometry will accommodate that ligament. More specific indications and contraindications are listed below:

Indications

u Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,
l Rheumatoid arthritis,
. Correction of functional deformity,
Post-traumatic loss of joint anatomy, particularly when there is patello-femoral L erosion, dysfunction or prior patellectomy; and,
I Irreparable fracture of the knee

Contraindications

Absolute contraindications include:

: Overt infection.
I Distant foci of infections (which may cause hematogenous spread to the implant site),
Rapid disease progression as manifested by joint destruction or bone absorption . apparent on roentgenogram,
트 Skeletally immature patients
Cases where there is poor bone stock which would make the procedure unjustifiable, ■

Conditions presenting an increased risk of failure include:

피 Uncooperative patient or patient with neurological disorders who is incapable of following instructions.
트 Osteoporosis,
트 Metabolic disorders which may impair bone formation,
Osteomalacia, and ■
" Previous arthrodesis

The subject Duracon® Extra Small CS Lipped Tibial Insert is an ultra-high molecular weight polyethylene tibial insert designed to be used with the femoral, tibial, and patellar

{2}------------------------------------------------

Duracon® CS Lipped Extra Small Tibial Insert Confidential

components of the Duracon® Total Knee System. This insert is available in an extrasmall size in the following thicknesses: 9mm, 11mm, 13mm, and 16mm. The subject insert has a dished articulating surface geometry to provide anatomic rollback, flexionextension and internal-external rotation. The subject tibial insert features a raised anterior eminence designed to provide greater anterior constraint in situations where the posterior cruciate ligament is not present or not functional. This anterior eminence is designed to provide substitution for the posterior cruciate ligament if it is not present or cannot be preserved.

The subject Duracon® CS Lipped Extra Small Tibial Insert features the same locking mechanism as the previously released Duracon® Condylar and AP Lipped Tibial Insert.

Engineering analyses were presented to characterize the function of the subject tibial insert, and to demonstrate substantial equivalence to other legally marketed devices.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 3 2003

Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401

Re: K023724

Trade/Device Name: Duracon® CS Lipped Extra Small Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 4, 2002 Received: November 5, 2002

Dear Ms. Crowe:

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.

{4}------------------------------------------------

Page 2 - Ms. Margaret F. Crowe

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) 594-4639. 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 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.

for Mark N. Milken

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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Page 1 of 2

Duracon® CS Lipped Extra Small Tibial Insert 510(k) Premarket Notification Confidential

510(k) Number (if known): Kのレ3フマイ

u Device Name: Duracon® CS Lipped Extra Small Tibial Insert
The Duracon® CS (Condylar Stabilizing) Lipped Extra Small Tibial Insert is intended to be used with Duracon® Extra Small Universal and Cruciform tibial baseplates, Duracon® Cruciate Retaining femoral components and Duracon® patellar components as part of a total knee system in primary cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments should be intact if this insert is utilized. This tibial insert may also be used in situations where the posterior cruciate ligament is present - its geometry will accommodate that ligament. More specific indications and contraindications are listed below:

Indications

Noninflammatory degenerative joint disease including osteoarthritis, traumatic 트
arthritis or avascular necrosis,
비 Rheumatoid arthritis,
1 Correction of functional deformity,
Post-traumatic loss of joint anatomy, particularly when there is patello-femoral 제 erosion, dysfunction or prior patellectomy; and,
Irreparable fracture of the knee

Contraindications

Absolute contraindications include:

. Overt infection.
제 Distant foci of infections (which may cause hematogenous spread to the implant site),

Mark N. Mckenna
(Division Sign-Off)

al, Res prative

510(k) Number

{6}------------------------------------------------

Rapid disease progression as manifested by joint destruction or bone absorption 제 apparent on roentgenogram,
Skeletally immature patients l
Cases where there is poor bone stock which would make the procedure unjustifiable, u

Conditions presenting an increased risk of failure include:

Uncooperative patient or patient with neurological disorders who is incapable of . following instructions,
. Osteoporosis,
Metabolic disorders which may impair bone formation, ■
Osteomalacia, and
비 Previous arthrodesis

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR 801.109)

Over-the-Counter-Use ~~fact~~ No
(per 21 CFR

Mark N. Milken

ivision Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number -

Regulation Number and Section

§ 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.