(90 days)
No
The summary describes a mechanical implant (tibial insert) and its intended use, focusing on material, design features, and mechanical testing for equivalence. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an orthopedic implant (tibial insert) used in total knee arthroplasty to replace damaged joint surfaces and restore function, rather than to treat symptoms or disease.
No
The device is a knee implant (tibial insert) used in total knee arthroplasty, which is a treatment rather than a diagnostic tool.
No
The device description clearly indicates it is a physical implant (tibial inserts) made from materials and designed with specific mechanical features for total knee arthroplasty. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Duracon® Posteriorly Stabilizer (PS) Lipped Tibial Inserts are components of a total knee system intended for surgical implantation in the knee joint during total knee arthroplasty. This is an in vivo procedure (performed within the living body), not an in vitro test.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes related to analyzing samples outside the body.
Therefore, the Duracon® Posteriorly Stabilizer (PS) Lipped Tibial Inserts are a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Duracon® Posteriorly Stabilized 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
Product codes
JWH
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.
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)
Mechanical testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 1 0 2001
510(k) Summarv Duracon® PS Lipped Tibial Inserts
Image /page/0/Picture/2 description: The image shows handwritten text that appears to be a combination of letters and numbers. The first line reads 'K012172', and the second line reads '1 OF 4'. The handwriting is somewhat stylized, with distinct shapes for each character, and the text is presented in a clear, legible manner against a white background.
510(k) Summary Duracon® PS Lipped Tibial Insert
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp.
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary-Catherine Dillon
Regulatory Affairs Specialist
and
Susan Krasny, PhD
Director, 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 Prosthesis
21 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
1
Image /page/1/Picture/1 description: The image shows handwritten text on a white background. The text on the top line reads 'K012172'. The text on the bottom line reads '20F4'. The handwriting appears to be somewhat stylized and the numbers are clearly written.
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.
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
2
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.
3
Image /page/3/Picture/1 description: The image shows handwritten text on a white background. The text "K012172" is written in the top half of the image. Below that, the text "4 OF 4" is written in a smaller font size.
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.
4
Image /page/4/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. Inside the circle is a stylized image of an eagle.
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.
5
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,
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
6
510(k) Number (if known): K O la | 7 à
Device Name: Duracon® Posteriorly Stabilized Lipped Tibial Insert
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 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