(50 days)
Not Found
No
The document describes a mechanical hip stem and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a prosthetic replacement for the proximal portion of the femur used during hip arthroplasty, which is a medical treatment aimed at restoring function and alleviating pain, fitting the definition of a therapeutic device.
No.
The document explicitly states that the device is intended for "prosthetic replacement of the proximal portion of the femur during hip arthroplasty," indicating it is a therapeutic device, not a diagnostic one. While it mentions "Specific diagnostic indications," these refer to the conditions for which the device is used, not that the device itself performs diagnostics.
No
The device description clearly describes a physical hip stem, a hardware component used in hip arthroplasty. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the APR-T Revision Hip Stem is for "prosthetic replacement of the proximal portion of the femur during hip arthroplasty." This describes a surgical implant used in vivo (within the body) to replace a damaged anatomical structure.
- Device Description: The description details the physical characteristics of a surgical implant (femoral replacement component, porous coating, collar, etc.).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The APR-T Revision Hip Stem is intended for prosthetic replacement of the proximal portion of the femur during hip arthroplasty. This hip stem can be used for total hip replacements (i.e., replacements where both the femur and acetabulum are replaced) or for hemi-arthroplasties where the hip stem-head assembly articulates directly with wellpreserved articular cartilage. For this indication, the stem must be paired with one of the following Sulzer Orthopedics endoprosthesis:
- the Unipolar with 12/14 Taper, cleared for use via 510(k)s K833403 and K934159, or
- the Bipolar component which was cleared for use via 510(k)s K833404 and K873815 and is . indicated for use with a CoCr modular femoral head.
Specific diagnostic indications include:
- Patient conditions of inflammatory degenerative joint disease (e.g., theumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis);
- Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and,
- Revision of previously failed hip arthroplasty.
The APR-T Revision Hip Stern is intended for use with or without bone cement.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
The APR-T Revision Hip Stem is part of a family of femoral replacement components which are used during primary and revision hip arthroplasties. Its proximal design features an asymmetric wedge and circumferential CSTi ™ porous coating. In addition, a porouscoated medial collar helps achieve improved proximal fixation.
The stem's anatomic design follows the natural curve of the diaphyseal canal for better fit, and features a coronal slot at the distal end to reduce stiffness in the larger sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal portion of the femur, hip
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K833403, K934159, K833404, K873815
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the use of zirconia ceramic heads with the femoral stems listed below.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | April 1, 1998 |
| Contact Person: | Mitchell A. Dhority
Manager, Regulatory Affairs |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous coated
uncemented prosthesis, 21 CFR 888.3358 |
| Common/Usual Name: | Total Hip Prosthesis, Semi-constrained |
| Trade/Proprietary Name: | APR-T® Revision Hip Stem |
SPECIFIC DIAGNOSTIC INDICATIONS
The APR-T Revision Hip Stem is intended for prosthetic replacement of the proximal portion of the femur during hip arthroplasty. This hip stem can be used for total hip replacements (i.e., replacements where both the femur and acetabulum are replaced) or for hemi-arthroplasties where the hip stem-head assembly articulates directly with wellpreserved articular cartilage. Specific diagnostic indications include:
- Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid arthritis) . and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis) :
- . Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and,
- Revision of previously failed hip arthroplasty. .
The APR-T Revision Hip Stem is intended for use with or without bone cement.
PRODUCT DESCRIPTION
The APR-T Revision Hip Stem is part of a family of femoral replacement components which are used during primary and revision hip arthroplasties. Its proximal design features an asymmetric wedge and circumferential CSTi ™ porous coating. In addition, a porouscoated medial collar helps achieve improved proximal fixation.
The stem's anatomic design follows the natural curve of the diaphyseal canal for better fit, and features a coronal slot at the distal end to reduce stiffness in the larger sizes.
1
SUBSTANTIAL EQUIVALENCE
This 510(k) is being submitted in response to an update of the design such that certain features are uniform across the entire APR stem line. The characteristics of the APR-T Revision Stem, either alone or in combination, are substantially equivalent to the following legally marketed predicate Sulzer Orthopedics and/or competitive devices in terms of intended use, materials and design characteristics: the APR® Collared Revision Stem (Sulzer Orthopedics Inc.), the APR® Porous Hip Stem (Sulzer Orthopedics Inc.), the BLAS™ Total Hip Prosthesis (Zimmer, Inc.), the PCA ™ Long Stem (Howmedica, a Division of Pfizer Hospital Products Group, Inc.), and the Natural-Hip™ Porous Stem (Sulzer Orthopedics Inc.).
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, with three curved lines representing the body and head. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1998
Ms. Shavawn Evans Parduhn Requlatory Affairs Specialist Sulzer Medica Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717
K981211 Re : APR-T® Revision Stem Trade Name: Requlatory Class: II Product Codes: LPH and JDI Dated: April 1, 1998 Received: April 2, 1998
Dear Ms. Parduhn:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, 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 (QS) for Medical Devices: General requlation (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.
3
Page 2 - Ms. Shavawn Evans Parduhn
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,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MAY-14-98 THU 15:25
Page 1 of 1
510(k) Number (if known): K981211
Device Name: APR-T Revision Hip Stem
Indications For Use:
The APR-T Revision Hip Stem is intended for prosthetic replacement of the proximal portion of the femur during hip arthroplasty. This hip stem can be used for total hip replacements (i.e., replacements where both the femur and acetabulum are replaced) or for hemi-arthroplasties where the hip stem-head assembly articulates directly with wellpreserved articular cartilage. For this indication, the stem must be paired with one of the following Sulzer Orthopedics endoprosthesis:
" in "w
- the Unipolar with 12/14 Taper, cleared for use via 510(k)s K833403 and K934159, or ●
- the Bipolar component which was cleared for use via 510(k)s K833404 and K873815 and is . indicated for use with a CoCr modular femoral head.
Specific diagnostic indications include:
-
- Patient conditions of inflammatory degenerative joint disease (e.g., theumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis);
-
- Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and,
-
- Revision of previously failed hip arthroplasty.
OR
The APR-T Revision Hip Stern is intended for use with or without bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
biollez
Prescription Use
Over-The Counter Use
(Optional Format 1-2-96)