(204 days)
The DePuy Proximal Femoral Replacement Prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty for replacing the hip joint in the following indications, as appropriate: 1) a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis, 2) avascular necrosis of the femoral head, 3) acute traumatic fracture of the femoral head or neck, 4) failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement, and 5) certain cases of ankylosis.
The DePuy Proximal Femoral Replacement Prosthesis is indicated for uncemented and cemented use as the femoral component in total hip arthroplasty for replacing the hip joint in the following indications, as appropriate: 1) a severely painful and/or a severely disabled joint resulting from osteoarthritis, or theumatoid arthritis, 2) avascular necrosis of the femoral head, 3) acute traumatic fracture of the femoral head or neck, 4) failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement, and 5) certain cases of ankylosis. It is a porous coated (except for the tapered distal tip), straight, cast Co-Cr-Mo stem available in three femoral sizes. The stem has a driving platform, a self-locking 12/14, 0540" taper for attachment of interchangeable modular femoral heads.
This 510(k) premarket notification is for the DePuy Proximal Femoral Replacement Prosthesis, a hip prosthesis.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that this 510(k) summary does not present acceptance criteria or quantitative performance data in the way you might expect for a modern AI/device study. The basis of clearance for this device in 1997 is substantial equivalence to previously cleared predicate devices, not performance against predefined acceptance criteria. Therefore, the "acceptance criteria" here are implicitly the characteristics and intended use of the legally marketed predicate devices.
| Acceptance Criteria (Implicit from Predicate Devices) | Reported Device Performance (Characteristics of DePuy PFR Prosthesis) |
|---|---|
| Intended Use: - Femoral component in total hip arthroplasty - Replacing hip joint for: osteoarthritis, rheumatoid arthritis, avascular necrosis, traumatic fracture, failed previous surgery, ankylosis | Intended Use: - Femoral component in total hip arthroplasty - Replacing hip joint for: osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis of femoral head, acute traumatic fracture of femoral head or neck, failed previous surgery (joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, other total hip replacement), certain cases of ankylosis. - Uncemented and cemented use (similar to Solution Hip Prosthesis). |
| Material: - Co-Cr-Mo alloy (for Porocoat Proximal Femoral Third Prosthesis and Solution Hip Prosthesis) or Ti-6Al-4V (for Proximal Femur Replacement Stem). | Material: - Cast Co-Cr-Mo stem (identical to Porocoat Proximal Femoral Third Prosthesis and Solution Hip Prosthesis). |
| Porous Coating Placement: - Various placements on predicate devices (e.g., total stem except distal tip, distal stem, entire stem). | Porous Coating Placement: - Porous coated (except for the tapered distal tip) - identical to Solution Hip Prosthesis. |
| Distal Tip Design: - "Bullet" tapered (Porocoat Proximal Femoral Third, Solution Hip) or "rounded" non-tapered (Proximal Femur Replacement Stem). | Distal Tip Design: - "Bullet" tapered distal tip (similar to Porocoat Proximal Femoral Third and Solution Hip Prosthesis). |
| Collar/Stem Feature: - Collarless, mid-stem "step", or collar. | Collar/Stem Feature: - Collarless (similar to Proximal Femur Replacement Stem). |
| Modularity: - Designed to accept modular femoral heads or non-modular. | Modularity: - Designed to accept modular femoral heads (similar to Proximal Femur Replacement Stem and Solution Hip Prosthesis). Specifically, self-locking 12/14, 0540" taper for attachment of interchangeable modular femoral heads. |
| General Design: - Basic design (e.g., 12/14 taper) (of Proximal Femur Replacement Stem). | General Design: - Basic design with a 12/14 taper (unchanged from Proximal Femur Replacement Stem cleared in 1990). |
| Manufacturing Process: | Manufacturing Process: - Unchanged from Proximal Femur Replacement Stem cleared by FDA in 1990. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a 510(k) submission based on substantial equivalence, primarily comparing design and material specifications to predicate devices. There is no mention of a "test set" in the context of clinical performance data in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Substantial equivalence claims typically do not involve establishing ground truth from a test set with expert adjudicators. The "ground truth" for the clearance is essentially the regulatory status and established safety/effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
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 hip prosthesis, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the legally marketed predicate devices, as determined by the FDA. The submission demonstrates that the new device is "substantially equivalent" to these predicates.
8. The Sample Size for the Training Set
Not applicable. There is no training set involved as this is a physical medical device clearance based on substantial equivalence to existing products, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned in this submission.
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@004 K970241
AUG 1 4 1997
10+2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988 |
|---|---|
| 510(K) CONTACT: | Sally FoustClinical Affairs Associate(219) 372-7455FAX (219) 267-7098e mail: Sally_Foust@ccgate.depuy.com |
| TRADE NAME: | DePuy Proximal Femoral Replacement Prosthesis |
| COMMON NAME: | Hip Prosthesis |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrainedporous coated uncemented prosthesis |
| DEVICE PRODUCT CODE: | 87LPH |
| SUBSTANTIALLYEQUIVALENT DEVICES: | •Porocoat Proximal Femoral Third Prosthesis•Proximal Femur Replacement Stem•Solution Hip Prosthesis•5/8 Porocoat AML Hip Prosthesis |
DEVICE DESCRIPTION AND INTENDED USE: The DePuy Proximal Femoral Replacement Prosthesis is indicated for uncemented and cemented use as the femoral component in total hip arthroplasty for replacing the hip joint in the following indications, as appropriate: 1) a severely painful and/or a severely disabled joint resulting from osteoarthritis, or theumatoid arthritis, 2) avascular necrosis of the femoral head, 3) acute traumatic fracture of the femoral head or neck, 4) failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement, and 5) certain cases of ankylosis. It is a porous coated (except for the tapered distal tip), straight, cast Co-Cr-Mo stem available in three femoral sizes. The stem has a driving platform, a self-locking 12/14, 0540" taper for attachment of interchangeable modular femoral heads.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Proximal Femoral Replacement Prosthesis is similar to the Porocoat Proximal Femoral Third Prosthesis, Proximal Femur Replacement Stem, Solution Hip Prosthesis and 5/8 Porocoat AML Hip Prosthesis which have been previously cleared by FDA. The intended use of the Proximal Femoral Replacement Prosthesis is for uncemented and cemented applications just like the Solution Hip Prosthesis, whereas the Porocoat Proximal Femoral Third Proximal Femur Replacement Stem is intended for cemented use only. The stem and porous coating material, Co-Cr-Mo alloy, for the Proximal Femoral Replacement Prosthesis is identical to that of the Porocoat Proximal Femoral Third Prosthesis and the Solution Hip Prosthesis, whereas the stem and porous coating material for the
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Proximal Femur Replacement Stem is Ti-6Al-4V. All of the above stems are porous coated. The placement of the porous coating on the total stem, except for the distal tapered tip, for the Proximal Femoral Replacement Prosthesis is identical to that of the Solution Hip Prosthesis, whereas the porous coating for the Porocoat Proximal Femoral Third Prosimal Femur Replacement Stem is on the distal stem and the entire stem respectively. The Proximal Replacement Prosthesis, Porocoat Proximal Femoral Third Prosthesis, and the Solution Hip Prosthesis each has a "bullet" tapered distal tip, whereas the Proximal Femur Replacement Stem has a "rounded" non-tapered distal tip. The Proximal Femoral Replacement Prosthesis and the Proximal Femur Replacement Stem are collarless, whereas the Porocoat Proximal Femoral Third Prosthesis has a mid stem "step" and the Solution Hip Prosthesis has a collar. The Proximal Femoral Replacement Prosthesis, the Proximal Femur Replacement Stem and the Solution Hip Prosthesis are designed to accept modular femoral heads, whereas the Porocoat Proximal Femoral Third Prosthesis is a non-modular design with the femoral head attached.
The subject Proximal Femoral Replacement Prosthesis is similar to the Proximal Femur Replacement Stem previously cleared by FDA with the exception of the change in taper/neck design, the tapered distal stem without porous coating, the material change to Co-Cr-Mo, and the addition of an uncemented use indication. The manufacturing process, intended use (with the exception of the additional indication of uncemented use) and the basic design of the Proximal Femoral Replacement Prosthesis with a 12/14 taper have not changed from those of the Proximal Femur Replacement Stem cleared by FDA in 1990.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sally Foust Clinical Affairs Associate DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
AUG 1 4 1997 ... .......
Re : K970241 DePuy Proximal Femoral Replacement Trade Name: (PFR) Prosthesis Requlatory Class: II Product Codes: LPH, JDI, and LZO Dated: June 19, 1997 Received: June 20, 1997
Dear Ms. Foust:
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 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 (Fremarket 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. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,
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Page 2 - Ms. Sally Foust
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 requlations.
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.
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 (301) 443-6597 or at its Internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Joseph
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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510(k) Number (if known) K970241
Device Name DePuy Proximal Femoral Replacement Prosthesis
Indications for Use:
The DePuy Proximal Femoral Replacement Prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty for replacing the hip joint in the following indications, as appropriate: 1) a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis, 2) avascular necrosis of the femoral head, 3) acute traumatic fracture of the femoral head or neck, 4) failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement, and 5) certain cases of ankylosis.
OR
Concurrence of CDRH, Office of Device Evaluation
poodes
Prescription Use _
Over-The Counter Use __ (Per 21 CFR 801.109)
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.