(88 days)
No
The device description and performance studies focus on the mechanical properties and compatibility of a physical hip stem, with no mention of AI or ML.
Yes
The device is intended for the relief of pain and restoration of function following various conditions affecting the hip, which are therapeutic indications.
No
The TaperFit Hip Stem is a prosthetic device (an implant) used for the relief of pain and restoration of the hip joint, not for diagnosing conditions.
No
The device description clearly states it is a physical hip stem made of stainless steel, which is 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 clearly describes a surgical implant for the relief of pain and restoration of function in the hip joint due to various conditions. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The description details a physical implant made of stainless steel, designed to be surgically inserted into the body. This is characteristic of a medical device, not an IVD which typically involves testing samples outside the body.
- Performance Studies: The performance studies mentioned are non-clinical mechanical and structural tests (FEA, fatigue testing, etc.) and a statement that clinical testing was not necessary for this submission. IVD performance studies would typically involve evaluating the accuracy and reliability of the diagnostic test against a reference standard using biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
Therefore, the TaperFit Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TaperFit Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip revision. The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar Prosthesis hemi-arthroplasty femoral heads.
The TaperFit Hip Stem is indicated for cemented, single use only.
Product codes (comma separated list FDA assigned to the subject device)
JDI, JDG, KWY
Device Description
The 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 (E100.XXX cleared in K003666) and Trinity CoCrMo modular femoral heads (E321.XXX cleared in K093472, K110087, K122305, K123705, K130128, K130343 and K131647). The stem is available in sizes, 0 through 4 with 3 offsets 50mm, 45mm, and 38mm, as well as a CDH option with a 36mm offset.
The TaperFit Hip Stem was originally cleared in K142761. This submission is being made to modify the indications for use to include hemi-arthroplasty when used with previously cleared Corin hemi-arthroplasty femoral heads as compatible components. The Corin CoCr Modular 26mm heads (E100.X26) have been cleared as compatible components of the Taper-Fit Hip stem (K003666). The Corin CoCr Modular 26mm heads (E100.X26) are part of the construct of the bipolar heads. Included in this submission is the Corin Bipolar Femoral Head (K925897) as a compatible component, which is indicated for hemi-arthroplasty.
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)
Non-clinical testing and analysis included FEA, mechanical fatigue testing, static testing, rotational torque testing, fretting and corrosion testing, and range of motion testing. This testing was performed and submitted in the previous TaperFit and Taper-Fit Hip Stem submissions (K142761, K992234, and K003666).
Clinical testing was not necessary in this Traditional 510(k).
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.
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.
K093472, K110087, K122305, K123705, K130128, K130343, K131647, K925897
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2016
Corin USA Limited Ms. Diana L. Nader-Martone Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607
Re: K153725
Trade/Device Name: 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, KWY Dated: December 23, 2015 Received: December 28, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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Indications for Use
510(k) Number (if known) K153725
Device Name TaperFit Hip Stem
Indications for Use (Describe)
The TaperFit Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar revision. Prosthesis hemi-arthroplasty femoral heads.
The TaperFit Hip Stem is indicated for cemented, single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 1. Applicant/Sponsor:
Distributor | Corin USA
5670 W. Cypress Street
Suite C
Tampa, Florida 33607
Establishment Registration No.: 1056629 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Diana L. Nader-Martone
Regulatory Affairs Associate
Corin USA
813-977-4469
diana.nader-martone@coringroup.com
Kathy Trier
VP Global Regulatory and Clinical Affairs
Corin USA
813-977-4469
kathy.trier@coringroup.com |
| 3. Date: | March 24, 2016 |
| 4. Proprietary Name: | TaperFit Hip Stem |
| 5. Common Name: | Hip Prosthesis |
| 6. Product Code(s): | JDI, JDG, KWY |
7. Classification Name:
21CFR 888.3350 – Hip joint metal/polymer semi-constrained cemented prosthesis 21CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis 21CFR 888.3360 – Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
8. Legally Marketed Devices to which Substantial Equivalence is claimed:
4
9. Device Description:
The 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 (E100.XXX cleared in K003666) and Trinity CoCrMo modular femoral heads (E321.XXX cleared in K093472, K110087, K122305, K123705, K130128, K130343 and K131647). The stem is available in sizes, 0 through 4 with 3 offsets 50mm, 45mm, and 38mm, as well as a CDH option with a 36mm offset.
The TaperFit Hip Stem was originally cleared in K142761. This submission is being made to modify the indications for use to include hemi-arthroplasty when used with previously cleared Corin hemi-arthroplasty femoral heads as compatible components. The Corin CoCr Modular 26mm heads (E100.X26) have been cleared as compatible components of the Taper-Fit Hip stem (K003666). The Corin CoCr Modular 26mm heads (E100.X26) are part of the construct of the bipolar heads. Included in this submission is the Corin Bipolar Femoral Head (K925897) as a compatible component, which is indicated for hemi-arthroplasty.
10. Intended Use / Indications:
The TaperFit Hip Stem is indicated for the relief of pain and restoration of hip function following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip revision. The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar Prosthesis hemi-arthroplasty femoral heads.
The TaperFit Hip Stem is indicated for cemented, single use only.
11. Summary of Technologies / Substantial Equivalence:
The TaperFit Hip Stem, subject of this submission, and the predicate TaperFit Hip Stem (K142761) are identical in design, materials, coating, and sizes and similar in terms of intended use/indications for use. Additionally, the TaperFit Hip Stem, subject of this submission, and the predicates, Taper-Fit Hip Stem (K992234 and K003666) are identical in materials, and coating, and similar in terms of design, sizes, and intended use/indications for use. Based on these similarities, Corin believes that the TaperFit Hip Stem is substantially equivalent to the predicate devices.
12. Non-Clinical Testing:
5
Non-clinical testing and analysis included FEA, mechanical fatigue testing, static testing, rotational torque testing, fretting and corrosion testing, and range of motion testing. This testing was performed and submitted in the previous TaperFit and Taper-Fit Hip Stem submissions (K142761, K992234, and K003666).
13. Clinical Testing:
Clinical testing was not necessary in this Traditional 510(k).