The Duracon® Posteriorly Stabilizer (PS) Lipped Tibial Inserts are intended to be used with legally marketed Duracon® tibial baseplates and wedges, femoral components, and patellar components as part of a total knee system in primary or revision 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 may or may not be used for revision of a failed prosthesis.

Indications

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

Device Description

The Duracon® PS Lipped tibial inserts share the same critical design features as the predicate Duracon® Stabilized tibial inserts. They both have the same snap-fit locking mechanism, augmented by a locking screw, for mating with the current Duracon® tibial baseplates (K915512). The subject Duracon inserts are intended to be used with current Duracon® femoral and patellar components. The subject inserts will be available in the same range of sizes and thicknesses and are manufactured from the same materials as the current Duracon® Stabilized inserts.

The subject inserts have an anterior/posterior (A/P) lipped feature to enhance femoral/tibial implant anterior stability in full extension. In addition, the subject inserts incorporate a patellar cut-out feature to improve patellar tracking.

AI/ML Overview

This document, K012172, is a 510(k) Summary for the Duracon® PS Lipped Tibial Insert. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than presenting novel clinical study data.

Therefore, the provided text does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving those criteria are met.

Here’s why and what can be extracted:

Acceptance Criteria and Reported Device Performance: The document states, "Mechanical testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts." It does not provide specific quantitative acceptance criteria (e.g., specific thresholds for wear, fatigue strength, range of motion) or the actual results of these tests. It only asserts that the new device shares critical design features and uses the same materials and manufacturing methods as the predicate device.
Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Mechanical testing." No further details about this testing (e.g., type of tests, parameters, results, sample sizes) are provided.

Therefore, it is not possible to complete the requested table and answer many of the questions based on the provided text.

However, I can extract the general nature of the evidence and the claim made:

Summary of Device Performance Evidence (Based on available information):

Claim: The Duracon® PS Lipped Tibial Inserts are substantially equivalent to the predicate Duracon® Stabilized Tibial Inserts (K932070 and K936292).
Evidence Type: Mechanical testing.
Rationale for Equivalence:
- Shared critical design features (snap-fit locking mechanism, augmented by a locking screw).
- Intended use is identical.
- Available in the same range of sizes and thicknesses.
- Manufactured from the same materials.
- Fundamental scientific technology, basic design concepts, and manufacturing methods have not changed.

Unable to Extract from the Provided Text:

Specific Acceptance Criteria: Not detailed.
Specific Reported Device Performance: Not detailed beyond the assertion of substantial equivalence.
Sample size used for the test set: Not mentioned.
Data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for mechanical testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is a medical device, not an AI diagnostic tool).
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for mechanical testing.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In essence, this document is a regulatory submission demonstrating substantial equivalence based on design, materials, and mechanical testing that supports that equivalence, rather than a detailed report of a clinical study or specific acceptance criteria for performance.

Summary

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OCT 1 0 2001

510(k) Summarv Duracon® PS Lipped Tibial Inserts

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510(k) Summary Duracon® PS Lipped Tibial Insert

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677
Contact Person:	Mary-Catherine DillonRegulatory Affairs SpecialistandSusan Krasny, PhDDirector, Regulatory Affairs
Date of Summary Preparation:	July 10, 2001
Device Identification
Proprietary Name:	Duracon® PS Lipped Tibial Insert
Common Name:	Knee Prosthesis
Classification Name and Reference:	Knee Joint, Patellofemorotibial,Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis21 CFR '888.3560

Predicate Device Identification

The Duracon® PS Lipped Tibial Bearing Inserts are substantially equivalent to the Duracon® Stabilized Tibial Inserts cleared via K932070 and K936292.

Device Description

The Duracon® PS Lipped tibial inserts share the same critical design features as the predicate Duracon® Stabilized tibial inserts. They both have the same snap-fit locking

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mechanism, augmented by a locking screw, for mating with the current Duracon® tibial baseplates (K915512). The subject Duracon inserts are intended to be used with current Duracon® femoral and patellar components. The subject inserts will be available in the same range of sizes and thicknesses and are manufactured from the same materials as the current Duracon® Stabilized inserts.

Intended Use

The intended use of the Duracon® PS Lipped tibial inserts is identical to that of the predicate Duracon® Stabilized tibial bearing inserts. As with the predicate inserts, the modified inserts are single use devices for use as part of a total knee system in primary or revision 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 may or may not be used for revision of a failed prosthesis.

Indications

Noninflammatory degenerative joint disease including osteoarthritis, traumatic . arthritis or avascular necrosis,
. Rheumatoid arthritis,
. Correction of functional deformity,
Revision procedures where other treatments or devices have failed, u

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K012172
3 OF 4

510(k) Summary Duracon® PS Lipped Tibial Inserts

adon't To Elped notal more
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:

6 Overt infection,
Distant foci of infections (which may cause hematogenous spread to the implant I site),
Rapid disease progression as manifested by joint destruction or bone absorption . apparent on roentgenogram,
l 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 l following instructions,
I Osteoporosis,
Metabolic disorders which may impair bone formation, l
. Osteomalacia, and
트 Previous arthrodesis

Performance Data

Mechanical testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts.

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Statement of Technological Comparison

The fundamental scientific technology of the current Duracon® PS Lipped tibial inserts has not changed with regard to the modified inserts. The modified inserts employ the same basic design concepts, the same materials, and the same manufacturing methods.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2001

Ms. Mary-Catherine Dillon Regulatory Affairs Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677

Re: K012172 Trade Name: Duracon® Posteriorly Stabilized Lipped 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: June 22, 2001 Received: July 12, 2001

Dear Ms. Dillon:

We have reviewed vour Section 510(k) premarket 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) 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. Mary-Catherine Dillon

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,

Mark N Millerson

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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510(k) Number (if known): K O la | 7 à

Device Name: Duracon® Posteriorly Stabilized Lipped Tibial Insert

Indications

Noninflammatory degenerative joint disease including osteoarthritis, traumatic 미 arthritis or avascular necrosis,
Rheumatoid arthritis, 트
Correction of functional deformity, l
Revision procedures where other treatments or devices have failed, 1
Post-traumatic loss of joint anatomy, particularly when there is patello-femoral . erosion, dysfunction or prior patellectomy; and,
. Irreparable fracture of the knee

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(CFR 801.109)	X	OR
-----------------------------------	---	----

Over-the Counter Use (Per 21

Musth N millersen
Division Sign-Off)

eral. Restorative

510(k) Number K012172

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.