(72 days)
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the relief of pain and restoration of hip function, which are therapeutic effects for conditions like arthritis and avascular necrosis.
No
Explanation: The device description states that the Taper-Fit Total Hip System is a total hip replacement system, indicated for the relief of pain and restoration of hip function. This indicates it is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components (femoral stems, modular femoral heads, distal stem centralizers) made from materials like stainless steel and zirconia ceramic, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of pain and restoration of hip function following various conditions affecting the hip joint. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The device is a physical implant (femoral stem, femoral heads, centralizers) designed to replace parts of the hip joint. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Anatomical Site: The device is implanted in the hip joint, which is an in-vivo application, not an in-vitro (outside the body) examination of specimens.
The information provided clearly describes a surgical implant used for total hip replacement, which falls under the category of medical devices used for treatment and restoration of function, not for in-vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Taper-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, posttraumatic disease effects, avascular necrosis and total hip revision.
Product codes
JDI, LZO
Device Description
The Taper-Fit Total Hip System is a total hip replacement system comprised of three types of components - femoral stems, modular femoral heads and distal stem centralizers. The femoral stem is manufactured from stainless steel in accordance with BS 7252 Part 9 [ISO 5832-7] - "Wrought Stainless Steel for Surgical Implants" or "High Nitrogen Stainless Steel" and is provided with a centralizer. The stem is double tapered, collarless and highly polished. The zirconia ceramic femoral heads are manufactured from high purity 3 mol% Yttria Stabilized Zirconia Polycrystals (Y-TZP). Cobalt-chrome femoral heads are manufactured from cast cobalt-chromium alloy to BS 7252 Part 4 [ISO 5832-4]. All femoral head types, by material, are available in short, standard and long neck sizes. The 12/14 bore on each head is designed to fit a 12/14 stem cone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The applicant was carried out testing to demonstrate SE to the predicate device. The results of the testing are located in Sections 8 and 9. SE is claimed to the predicate device based on identical femoral stem and head geometries/dimensions, in addition to, similar mechanical properties, as demonstrated in the test results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
FEB - 8 2001
510(k) SUMMARY
Date: 11/27/00
Applicant's name:
Corin USA 10500 University Center Drive, Suite 190 Tampa, FL 33612
Phone: (813) 977-4469 (813) 979-0042 Fax:
Contact person:
Joel Batts, Regulatory Affairs Manager
Summary
The purpose of this premarket notification submission is to gain clearance to market I he purpose of this premarket notifica.org six onia ceramic modular femoral heads with the previously approved Taper-Fit Total Hip System (K992234).
Substantial equivalence (SE) is claimed, herein, to the Taper-Fit Hip System as it was previously approved for use with stainless steel modular femoral heads.
The Taper-Fit Total Hip System is a total hip replacement system comprised of three The Tapel-I'll Total Thip Dystein is a tound heads and distal stem centralizers. types of components - remoral stems, modular is the "Hip joint, metal/ceramic/polymer, when used with modular cetailine renords normal is when used with cobaltsemi-constrained comentou probalsons the "Hip joint, metal/polymer, semiconstrained cemented prosthesis" classification applies.
The femoral stem is manufactured from stainless steel in accordance with BS 7252 Part 9 The lemoral stem is manufactar or High Nitrogen Stainless Steel" and is provided with a [150 5832-7] - bpcomeanshis rosalizer. The stem is double tapered, collarless and highly polished.
The zirconia ceramic femoral heads are manufactured from high purity 3 mol% Yttria Stabilized Zirconia Polycrystals (Y-TZP).
Cobalt-chrome femoral heads are manufactured from cast cobalt-chromium alloy to BS 7252 Part 4 [ISO 5832-4].
All femoral head types, by material, are available in short, standard and long neck sizes. The 12/14 bore on each head is designed to fit a 12/14 stem cone.
Section 2 Page 1 of 2
1
The system is indicated for the relief of pain and restoration of hip function following the I he system is indicated for the rener of pain and and inflammatic disease effects, avascular necrosis and total hip revision.
The sole difference between the device as submitted in the current submission and the I he sole alfference between the action as a submitted as approved for use with a stainless steel femoral head.
Pursuant to the comments of the FDA/Orthopedic Device Branch (see facsimile in Pursualit to the comments of the I Dr of Cheropeters to demonstrate SE to the Section 2), the applicant mas carrou cestion are located in Sections 8 and 9. As can be predicate device. The results of the testing we claim SE to the predicate device based on seen in Section + of the present scennerries/dimensions, in addition to, similar identical remoral stem and nead goometrics unlained allarines, as demonstrated in the test results.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human figures, possibly representing health, family, and community. The figures are abstract and appear to be reaching upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 8 2001
Mr. Joel K. Batts Regulatory Affairs Manager Corin USA 10500 University Center Drive, Suite 190 Tampa, Florida 33612
Re: K003666
Trade Name: Taper-Fit Total Hip System Regulatory Class: II Product Code: JDI, LZO Dated: November 27, 2000 Received: November 28, 2000
Dear Mr. Batts:
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 (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 (QS) 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.
3
Page 2 - Mr. Joel K. Batts
This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to ocgan mainer of substantial equivalence of your device to a premiarket nothleation. THE I Dri mixing or sassification 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 If you desire specific as for in vitro diagnostic devices), please contact the Office of and additionally 609.104-4659. Additionally, for questions on the promotion and Compliance at (301) 591-1699 contact the Office of Compliance at (301) 594-4639. advertising of your arritled, "Misbranding by reference to prematice Also, prease note the regation emergeneral information on your responsibilities under the nother (21 Cr Cr Cr on the Division of Small Manufacturers Assistance at its toll-free Act may of obtained at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Mark Millman
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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510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________
DEVICE NAME: Taper-Fit Total Hip System
INDICATIONS FOR USE:
Taper-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, posttraumatic disease effects, avascular necrosis and total hip revision.
Mark N. Wilkerson
Division Sign-Off) (Division of General, Restorative and Neurological Devices K003666
510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ > (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)