(29 days)
The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: - Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. - Avascular necrosis of the femoral head. 2. - Acute traumatic facture of the femoral head or 3. neck. - Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - Certain cases of ankylosis. 5.
The DePuy C-Stem System hip stem is a collarless, triple-tapered polished stem slim-profiled, manufactured from stainless steel. The C-Stem system also includes an end cap made from either gelatin or PMMA and PMMA centralizers.
The provided text is a 510(k) summary for the DePuy C-Stem™ System, a total hip joint replacement prosthesis. It does not contain acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, etc.).
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device (K982918 DePuy C-Stem System), rather than providing detailed performance studies against specific acceptance criteria.
The key points from the provided text are:
- Device: DePuy C-Stem™ System
- Classification: Class II Device (21 CFR 888.3350)
- Intended Use: Total hip arthroplasty to increase patient mobility and reduce pain.
- Indications for Use: Severely painful/disabled joint from various conditions (osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia), avascular necrosis, acute traumatic fracture, failed previous hip surgery, and certain cases of ankylosis.
- Substantial Equivalence Claim: The document states that "The fundamental scientific technology of the C-Stem System has not changed from the FDA cleared DePuy C-Stem System described in K982918. The intended use and indications for use have not changed. The material from which the additional end cap is manufactured has been changed to PMMA, the same material used to manufacture other legally marketed end cap devices."
- Approval Basis: Conformance with design control procedures and similarities in design, intended use, and indications for use to the predicate device.
Therefore, I cannot fill out the requested table or answer most of the questions because the provided text does not contain the necessary information regarding acceptance criteria or a performance study.
The document is a regulatory filing focused on demonstrating equivalence for market clearance, not on providing a study with specific performance metrics against pre-defined acceptance criteria for a new or significantly modified device requiring such studies.
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510(k) Summary
) Summary K013350
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910
Marcia J. Arentz Senior Regulatory Associate Phone: (219) 371-4944 FAX: (219) 371-4940
DePuy C-Stem™ System
Total Hip Joint Replacement Prosthesis
Class II Device per 21 CFR 888.3350:
Trade Name:
510(k) Contact:
Common Name:
Name of Sponsor:
Classification:
Device Product Code:
Substantially Equivalent Device:
Device Descriptions:
Intended use:
Indications for use:
pl/z
Code: 87JDI
prosthesis
No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems.
Hip joint metal/polymer semi-constrained cemented
K982918 DePuy C-Stem System
The DePuy C-Stem System hip stem is a collarless, triple-tapered polished stem slim-profiled, manufactured from stainless steel. The C-Stem system also includes an end cap made from either gelatin or PMMA and PMMA centralizers.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
- Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic facture of the femoral head or 3. neck.
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- Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. 5.
Substantial equivalence:
The fundamental scientific technology of the C-Stem System has not changed from the FDA cleared DePuy C-Stem System described in K982918. The intended use and indications for use have not changed The material from which the additional end cap is manufactured has been changed to PMMA, the same material used to manufacture other legally marketed end cap devices.
Based on conformance with the design control procedures requirements as specified in 21 CFR 820.30, similarities of design, the same indications for use and intended use, DePuy believes that the C-Stem end cap to be substantially equivalent to the FDA cleared C-Stem System originally cleared in K982918.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three overlapping shapes that resemble an abstract human form or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 7 2001
Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K013350
Trade Name: DePuy C-Stem™ System Regulation Number: 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: October 5, 2001 Received: October 9, 2001
Dear Ms. Arentz :
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rone would your bove 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, (Trefore, 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, oon 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 or any 1 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 CI K Pat 6077, acceins (21 (OS) 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. Marcia Arentz
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,
M.D.
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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NOV 0 7 2001
510(k) Number (if known): 上口|3350
Device Name: DePuy C-Stem™ System
Indications for Use:
The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing I other mp article of includion in patients where there is evidence of sufficient sound bone to seat the camaged inp youndents. Total hip replacement is indicated in the following conditions:
- l . A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, র্ব hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. ડ.
| Concurrence of CDRH, Office of Device Evaluation | |
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| -------------------------------------------------- | -- |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | KO 13350 |
|---|---|
| --------------- | ---------- |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
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| ---------------------- | -- |
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.