(77 days)
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:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Non Porous-coated femoral hip stem prostheses labeled "FOR PRESS-FIT OR CEMENTED USE" are indicated for press-fit uncemented use, or for use with bone cement.
The Response 2000 Hip Stem is manufactured from ASTM F-75 Co-Cr-Mo alloy. It is a smooth, straight-stem design, which will have a glass bead-blasted surface finish, a bullet-shaped distal tip, and is designed with a self-locking taper for use with a DePuy femoral head.
The provided text describes a 510(k) premarket notification for the DePuy Response 2000 Hip Stem, a femoral hip prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood for AI/ML device submissions.
The information provided pertains to:
- Device Description: The Response 2000 Hip Stem is made from ASTM F-75 Co-Cr-Mo alloy, has a smooth, straight-stem design with a glass bead-blasted surface finish, a bullet-shaped distal tip, and a self-locking taper for use with a DePuy femoral head.
- Intended Use & Indications: For press-fit or cemented use in total hip arthroplasties to increase patient mobility and reduce pain. Specific indications include osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery, and certain cases of ankylosis.
- Basis of Substantial Equivalence: The subject device is stated to be identical to predicate hip stem devices in straight stem geometry, materials, and indications.
To directly answer your numbered points based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document focuses on substantial equivalence based on design, materials, and indications, not performance metrics.
- Sample size used for the test set and the data provenance: This information is not present as no performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present as no ground truth establishment for a test set is described.
- Adjudication method for the test set: This information is not present as no test set or adjudication process is described.
- 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: This information is not present. This device is a mechanical hip stem, not an AI/ML device, so such a study would not be applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. This device is a mechanical hip stem, not an AI/ML algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
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Image /page/0/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo features a large, solid black circle to the left of the name "DePuy" in a bold, sans-serif font. Below the name is the text "a Johnson & Johnson company" in a smaller, italicized font. A horizontal line underlines the "DePuy" text, visually connecting it to the company affiliation.
Image /page/0/Picture/1 description: The image shows a handwritten number, K000392. The number is written in black ink on a white background. The handwriting is somewhat messy, but the number is still legible. The number appears to be a serial number or some other type of identification number.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581-0988 |
|---|---|
| 510(K) CONTACT: | Arlene C. Saull, RACSr. Regulatory AssociateDePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581-0988 |
| TRADE NAME: | ResponseTM 2000 Hip Stem |
| COMMON NAME: | Femoral Hip Prosthesis |
| CLASSIFICATION: | Class II, per 21 CFR, 888.3350 |
| DEVICE PRODUCT CODE: | 87 LZO Prosthesis, Hip, Semi-ConstrainedMetal/Ceramic/Polymer, Cemented or Non-porouUncemented. |
| SUBSTANTIALLYEQUIVALENT DEVICES: | DePuy Quantum Hip StemDePuy Modular Press-Fit (MPF) Hip (Std. & MMA)DePuy Vision AML Hip StemsDePuy AML MMA Hip Stem |
DEVICE DESCRIPTION:
The Response 2000 Hip Stem is manufactured from ASTM F-75 Co-Cr-Mo alloy. It is a smooth, straight-stem design, which will have a glass bead-blasted surface finish, a bullet-shaped distal tip, and is designed with a self-locking taper for use with a DePuy femoral head.
INDICATIONS AND INTENDED USE:
Intended Use:
The Response 2000 Hip Stern is intended for press-fit or cemented use in total bip arthroplasties.
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Indications:
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:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congcnital hip dysplasia.
-
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck ని.
- Failed previous hip surgery including joint reconstruction, internal fixation, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
Non Porous-Coated Press-Fit or Cemented Components:
Non Porous-coated femoral hip stem prostheses labeled FOR PRESS-FIT OR CEMENTED USE are indicated for press-fit uncemented use, or for use with bone cernent.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The subject devices are identical to the predicate hip stem devices, in that they have the same straight stem geometry, materials and indications.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing. The logo is black and white.
Public Health Service
APR 2 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Arlene C. Saull, RAC Senior Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K000392
Trade Name: Response 2000 Hip Stem Regulatory Class: II Product Code: LZO and JDI Dated: February 4, 2000 Received: February 7, 2000
Dear Ms. Saull:
We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Ms. Arlene C. Saull, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html" .
Sincerely yours,
Dime R. Lochner.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a solid black circle to the left of the name "DePuy" in a bold, sans-serif font. Below the name is a horizontal line, and beneath that, the text "a Johnson & Johnson company" is written in a smaller, cursive-like font.
INDICATIONS
510(k) Premarket Notification
510(k) Number (if known) K000392
Response™ 2000 Hip System Device Name
Note: (The package insert includes intended uselindications for several types of femoral components. The below text, which is (11th plants of the package insert (see Exhibit D), contains only the intended uselindications perinent to the Response 2000 Hip Stem.)
Indications for Use:
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:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 1. 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, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. న.
Non Porous-Coated Press-Fit or Cemented Components:
Non Porous-coated femoral hip stem prostheses labeled "FOR PRESS-FIT OR CEMENTED USE" are indicated for press-fit uncemented use, or for use with bone cement.
Concurrence of CDRH, Office of Device Evaluation:
OR
Domer R. Lochner
Division of Coural 510(k) Number KOC C
7 Prescription Use
Over-The Counter Use (Per 21 CFR 801.109)
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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.