(73 days)
The DePuy LPS Diaphyseal and Metaphyseal Sleeves are intended for use in primary and revision knee joint replacement in the treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty.
The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.
The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:
- malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
- revision cases for a failed previous prosthesis requiring extensive resection and replacement:
- severe trauma requiring extensive resection and replacement.
The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.
The DePuy LPS Diaphyseal Sleeve is a modular, porous-coated, cone-shaped component designed to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral and proximal tibial replacements. The existing LPS Metaphyseal Sleeve (K040281) is a modular, porous-coated, flared component designed for enhanced fit and fill of the metaphyseal region of the distal femur with femoral replacements. Both are manufactured from titanium alloy.
This 510(k) Pre-Market Notification provides information about a medical device rather than a study evaluating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes is not available in the provided document.
A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical trials or detailed performance studies.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document does not describe acceptance criteria and performance data in the way a clinical study or validation report would. The basis of substantial equivalence relies on similarity to predicate devices in intended use, indications for use, materials, and design, not on meeting specific quantitative performance metrics defined by acceptance criteria in a study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set or associated data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment is described for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described.
5. 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 device is a physical orthopedic implant (sleeves for knee replacement), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described.
8. The sample size for the training set
Not applicable. This device is a physical orthopedic implant, and as such, there is no "training set" in the context of an AI or software algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
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KO71417 Pose Is
AUG - 2 2007
510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46582Establishment Registration Number: 1818910 |
|---|---|
| 510(K) CONTACT: | Rhonda MyerRegulatory AffairsTelephone: (574) 371-4927Facsimile: (574) 371-4987Electronic Mail: Rmyer7@dpyus.jnj.com |
| DATE PREPARED: | May 16, 2007 |
| PROPRIETARY NAME: | LPS Diaphyseal and Metaphyseal Sleeves |
| COMMON NAME: | Diaphyseal and Metaphyseal Sleeve Components |
| CLASSIFICATION: | 888.3565 Knee joint patellofemorotibialmetal/polymer porous-coated uncementedprosthesis888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrainedcemented prosthesis |
| DEVICE PRODUCT CODE: | 87 MBH, JWH |
| SUBSTANTIALLY EQUIVALENTDEVICES: | DePuy Orthogenesis LPS System, K003182DePuy LPS Metaphyseal Sleeve, K040281DePuy Stability Hip Stem with Porocoat®,K934457 |
DEVICE DESCRIPTION:
The DePuy LPS Diaphyseal Sleeve is a modular, porous-coated, cone-shaped component designed to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral and proximal tibial replacements. The existing LPS Metaphyseal Sleeve (K040281) is a modular, porous-coated, flared component designed for enhanced fit and fill of the metaphyseal region of the distal femur with femoral replacements. Both are manufactured from titanium alloy.
INTENDED USE AND INDICATIONS:
Intended Use:
The DePuy LPS Diaphyseal and Metaphyseal Sleeves are intended for use in primary and revision knee joint replacement in the treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty.
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Indications for Use:
The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.
The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:
- . malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. . avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
- revision cases for a failed previous prosthesis requiring extensive resection and . replacement:
- . severe trauma requiring extensive resection and replacement.
The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of the DePuy LPS Diaphyseal and Metaphyseal Sleeves is shown by the similarity in intended use, indications for use, materials and design to the existing DePuy Orthogenesis LPS, K003182 cleared on June 27, 2001, DePuy LPS Metaphyseal Sleeves, K040281 cleared on July 09, 2004, and DePuy Stability Hip Stem with Porocoat®, K934457.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582
AUG - 2 2007
Re: K071417
Trade/Device Name: LPS Diaphyseal and Metaphyseal Sleeves Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: July 24, 2007 Received: July 25, 2007
Dear Ms. Myer:
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
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Page 2 - Ms. Rhonda Myer
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 vours.
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510 (k) Number (if known): K071417
Device Name: LPS Diaphyseal and Metaphyseal Sleeves
Indications for Use:
The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.
The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, The Dot af Er B is to it it to the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:
- malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone . tumors) requiring extensive resection and replacement;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. . pations benefitions of teoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
- revision cases for a failed previous prosthesis requiring extensive resection and . replacement;
- severe trauma requiring extensive resection and replacement. .
The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The porous-coated diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
Page 6 of 61
DePuy LPS Additional Information (K071417)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mark A. Mellerson | Page 1 of 1 | |
|---|---|---|
| (Division Sign-Off) | ||
| Division of General, Restorative, and Neurological Devices | ||
| 510(k) Number | K071417 | 5 |
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.