(111 days)
Not Found
No
The 510(k) summary describes a mechanical hip stem implant and its materials. There is no mention of software, image processing, AI, ML, or any data-driven components. The performance studies focus on mechanical testing and bacterial endotoxin testing, not algorithmic performance.
Yes
The device is intended to treat several medical conditions and relieve pain by replacing the damaged hip joint, which are characteristic functions of a therapeutic device.
No
Explanation: The device is a hip stem intended for joint replacement, not for diagnosing medical conditions.
No
The device description clearly states the device is a physical hip stem manufactured from titanium alloy with coatings, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Corin TriFit™ CF Hip Stem is a surgical implant designed to replace a damaged hip joint. It is a physical device implanted into the body, not used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
This device is a medical device, specifically a surgical implant.
N/A
Intended Use / Indications for Use
The indications for the Corin TriFit™ CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- · Correction of functional deformity
- · Treatment of non-union and femoral neck fractures of the proximal femur
- · Developmental Dysplasia of the Hip (DDH)
- Previously failed hip surgery
The Corin TriFit™ CF Hip Stem is indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LZO, KWL, KWY, LPH, MBL
Device Description
The Corin TriFit™ CF Hip Stem is a tapered stem design manufactured from titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2:1999, ASTM F1580-01) and calcium phosphate coating (ASTM F1609-08) applied. The Corin TriFit™ CF Hip Stem is available in a range of sizes in a 127° standard offset and a 127° lateralized high offset. The device is intended to be used with Corin 12/14 modular taper heads.
The TriFit™ CF Hip Stem is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
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 mechanical fatigue testing of the neck and stem and range of motion testing. The results of this testing show that the Corin TriFit™ CF Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
Bacterial Endotoxin Testing (BET) has been conducted on finished product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology.
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.
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
April 11, 2018
Corin USA Limited Rachel King Regulatory Affairs Associate 12750 Citrus Park Lane Tampa, Florida 33625
Re: K173880
Trade/Device Name: Corin TriFit™ CF Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH, LZO, KWL, KWY, LPH, MBL Dated: March 5, 2018 Received: March 6, 2018
Dear Ms. King:
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 forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K173880
Device Name Corin TriFit™ CF Hip Stem
Indications for Use (Describe) The indications for the Corin TriFit™ CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- · Correction of functional deformity
- · Treatment of non-union and femoral neck fractures of the proximal femur
- · Developmental Dysplasia of the Hip (DDH)
- Previously failed hip surgery
The Corin TriFit™ CF Hip Stem is indicated for cementless use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3. 510(K) SUMMARY
| 1. Applicant/Sponsor:
Distributor | Corin USA Limited
12750 Citrus Park Lane
Suite 120, Tampa, FL 33625
Establishment Registration No.: 1056629 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Rachel King, BSc (Hons)
Regulatory Affairs Associate
Corin Ltd
+44 1285 884733
rachel.king@coringroup.com
Lucinda Gerber, BA (Hons)
Global Regulatory Affairs Manager
Corin Ltd / Corin USA
1 (772) 321-2478
lucinda.gerber@coringroup.com |
| 3. Date: | December 20, 2017 |
| 4. Proprietary Name: | Corin TriFit™ CF Hip Stem |
| 5. Common Name: | Hip Prosthesis |
| 6. Product Code(s): | MEH, LZO, KWL, KWY, LPH, MBL |
| 7. Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis (21CFR 888.3353)
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented
prosthesis (21CFR 888.3390)
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
(21CFR 888.3360) |
8. Legally Marketed Devices to which Substantial Equivalence is claimed:
- Ortho Development Corporation Alpine Hip Stem (K141001) (Primary predicate) ●
- Corin TriFit™ TS Hip (K121563 and K153772) .
Device Description: 9.
The Corin TriFit™ CF Hip Stem is a tapered stem design manufactured from titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2:1999, ASTM F1580-01) and calcium phosphate coating (ASTM F1609-08) applied. The Corin TriFit™ CF Hip Stem is available in a range of sizes in a 127° standard offset and a 127° lateralized high offset. The device is intended to be used with Corin 12/14 modular taper heads.
The TriFit™ CF Hip Stem is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
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10. Intended Use / Indications:
The indications for the Corin TriFit™ CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- . Rheumatoid arthritis
- . Correction of functional deformity
- . Treatment of non-union and femoral neck fractures of the proximal femur
- Developmental Dysplasia of the Hip (DDH)
- . Previously failed hip surgery
The Corin TriFit™ CF Hip Stem is indicated for cementless use only.
11. Summary of Technologies / Substantial Equivalence:
The Corin TriFit™ CF Hip Stem is similar to the Ortho Development Corporation Alpine Hip Stem (K141001) stem in terms of materials, size, designs, performance, intended use and indications for use. The coating, a titanium plasma spray with a layer of calcium phosphate is identical to the TriFit™ TS Hip Stem (K121563, K153772) in terms of materials and performance. The design of the neck on the TriFit™ CF Hip Stem is identical to that of the TriFit™ TS Hip Stem (K121563, K153772). Based on these similarities, the TriFit™ CF Hip Stem is believed to be substantially equivalent to the predicate devices.
12. Non-Clinical Testing:
Non-clinical testing and analysis included mechanical fatigue testing of the neck and stem and range of motion testing. The results of this testing show that the Corin TriFit™ CF Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
Bacterial Endotoxin Testing (BET) has been conducted on finished product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology.
13. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the additional components of the Corin TriFit™ CF Hip Stem and the predicate devices.