(190 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a hip stem, with no mention of AI or ML.
Yes
The device is indicated for the relief of pain and restoration of hip function due to various medical conditions, which falls under the definition of a therapeutic purpose.
No
This device, the TaperFit Hip Stem, is an implant used for the relief of pain and restoration of hip function, directly addressing a medical condition rather than identifying or characterizing one. Its intended use describes a treatment, not a diagnosis.
No
The device description clearly describes a physical hip stem made of stainless steel, a hardware component.
Based on the provided text, 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 femoral hip stem, a physical implant used in hip replacement surgery. This is a surgical device, not a device used to examine specimens from the human body.
- Lack of IVD characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a person's health status based on such testing.
Therefore, the TaperFit Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TaperFit Hip Stem is indicated for the relief of pain and restoration of hip function following the effects of osteo, theumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip revision.
The TaperFit Hip Stem is indicated for cemented, single use only.
The TaperFit Hip Stem is intended for use in total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
Product codes (comma separated list FDA assigned to the subject device)
JDI, JDG
Device Description
The Corin TaperFit Hip Stem is a highly polished, double tapered, collarless, stainless steel femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from stainless steel in accordance with ISO 5832-9 -Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel and is provided with a polymethylmethacrylate (PMMA) Stem Centralizer. The stem is designed to be used in conjunction with Corin Eurocone CoCrMo modular femoral heads (K003666). The stem is currently available in sizes, 1 through 4 with 2 offsets 45mm and 38mm, as well as a CDH option with a 36mm offset.
The purpose of this submission is to add the 1-hole design of the TaperFit Hip Stem to the TaperFit range. This new design has a single rounded elliptical dove-tail hole on the lateral shoulder of the stem for the stem introducer, instead of 2 rounded or angulated introducer holes which the predicate devices have. In addition to the change in introducer hole design, this 510(k) adds size 0 stems to the 38mm and 45mm offsets, and sizes 0 through 4 in a 50mm offset.
The submission is also to modify the labeling for the TaperFit Hip Stem to add the previously cleared Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) as compatible components, intended for use with the TaperFit Hip Stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
skeletally mature patients
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)
Non-clinical testing and analysis included FEA, mechanical fatigue testing, static tensile testing, rotational torque testing and range of motion testing. The results of this testing show that the Corin TaperFit Hip Stem with a 1-hole design, and the size 0 stems, are expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices.
Clinical testing was not necessary to determine substantial equivalence between the Corin TaperFit Hip Stem and the predicate devices.
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.
K992234, K003666, K803126, K891454, K011623, K110290, K093472, K110087, K111481, K122305, K123705, K130128, K130343, K131647
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.
Not Found
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
§ 888.3350 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design. The profiles are facing to the right and are stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Corin USA Ms. Diana L. Nader-Martone Regulatory Affairs Associate 5670 W. Cypress Street Tampa, Florida 33607
Re: K142761
Trade/Device Name: Corin TaperFit Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, JDG Dated: March 6, 2015 Received: March 9, 2015
Dear Ms. Nader-Martone:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
April 3, 2015
1
Page 2 - Ms. Diana L. Nader-Martone
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. INDICATIONS FOR USE
510(k) Number (if known): _K142761
Device Name: Corin TaperFit Hip Stem
Indications for Use:
TaperFit Hip Stem is indicated for the relief of pain and restoration of hip function following the effects of osteo, theumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip revision.
The TaperFit Hip Stem is indicated for cemented, single use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
1. 510(K) SUMMARY
| 1. | Applicant/Sponsor: | Corin USA |
|---|---|---|
| 5670 W. Cypress Street | ||
| Suite C | ||
| Tampa, Florida 33607 | ||
| Establishment Registration No.: 1056629 | ||
| 2. | Contact Persons: | Diana L. Nader-Martone, MS |
| Regulatory Affairs Associate | ||
| Corin USA | ||
| 813-977-4469 | ||
| diana.nader-martone@coringroup.com | ||
| Lucinda Gerber, BA (Hons) | ||
| US Regulatory and Clinical Affairs Team Leader | ||
| Corin USA | ||
| 813-977-4469 | ||
| lucinda.gerber@coringroup.com | ||
| 3. | Date: | September 23, 2014 |
| 4. | Proprietary Name: | Corin TaperFit Hip Stem |
| 5. | Common Name: | Femoral Hip Stem |
| 6. | Product Codes: | IDI, IDG |
7. Classification Name:
21CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis
8. Legally Marketed Devices to which Substantial Equivalence is claimed:
- Corin Taper-Fit Hip Stem (K992234, K003666) .
- . Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290)
- Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, ● K130128, K130343 and K131647)
4
9. Device Description:
The Corin TaperFit Hip Stem is a highly polished, double tapered, collarless, stainless steel femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from stainless steel in accordance with ISO 5832-9 -Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel and is provided with a polymethylmethacrylate (PMMA) Stem Centralizer. The stem is designed to be used in conjunction with Corin Eurocone CoCrMo modular femoral heads (K003666). The stem is currently available in sizes, 1 through 4 with 2 offsets 45mm and 38mm, as well as a CDH option with a 36mm offset.
The purpose of this submission is to add the 1-hole design of the TaperFit Hip Stem to the TaperFit range. This new design has a single rounded elliptical dove-tail hole on the lateral shoulder of the stem for the stem introducer, instead of 2 rounded or angulated introducer holes which the predicate devices have. In addition to the change in introducer hole design, this 510(k) adds size 0 stems to the 38mm and 45mm offsets, and sizes 0 through 4 in a 50mm offset.
The submission is also to modify the labeling for the TaperFit Hip Stem to add the previously cleared Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) as compatible components, intended for use with the TaperFit Hip Stem.
10. Intended Use / Indications:
The TaperFit Hip Stem is intended for use in total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
TaperFit Hip Stem is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip revision.
The TaperFit Hip Stem is indicated for cemented, single use only.
11. Summary of Technologies/Substantial Equivalence:
The Corin TaperFit Hip Stem, subject of this submission, has the same intended use and indications
5
and is manufactured from the same materials as the Corin Taper-Fit Hip Stem (K992234 and K003666). Additionally, the Corin TaperFit Hip Stem, the subject device, is similar in design, compatible components and comes in a similar range of sizes as the predicate devices. Based on these similarities, Corin believes that the TaperFit Hip Stem is substantially equivalent to the predicate devices.
12. Non-Clinical Testing:
Non-clinical testing and analysis included FEA, mechanical fatigue testing, static tensile testing, rotational torque testing and range of motion testing. The results of this testing show that the Corin TaperFit Hip Stem with a 1-hole design, and the size 0 stems, are expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices.
13. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Corin TaperFit Hip Stem and the predicate devices.