(129 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical testing of a ceramic femoral head, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is used in hip replacement surgery to reinstate function following degenerative effects and correct functional deformity, which are therapeutic interventions.
No
The device description indicates that the Corin BIOLOX delta Modular Femoral Heads are components used in hip replacement surgery to restore function, not to diagnose a condition.
No
The device description clearly indicates it is a physical medical device (femoral heads made of ceramic composite) and describes nonclinical testing related to mechanical properties (burst strength, fatigue, pull-off). There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a surgical implant used to replace parts of the hip joint. It is a physical component (femoral head) that is implanted into the body to restore function.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples or providing diagnostic information about a patient's health status. The device's purpose is purely therapeutic and reconstructive.
Therefore, based on the provided information, the Corin BIOLOX delta Modular Femoral Heads are a medical device, specifically a surgical implant, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Corin BIOLOX delta Modular Femoral Heads are used in combination with femoral hip stems and ultra high molecular weight polyethylene (UHMWPE) acetabular cup liners to reinstate function following the degenerative effects of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity and
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin BIOLOX delta Modular Femoral Heads are intended for single use only.
Product codes
LZO
Device Description
BIOLOX delta material is an aluminum oxide / zirconia ceramic composite composed of approximately 75% aluminum oxide and approximately 25% zirconia.
The Corin BIOLOX delta Modular Femoral Heads are available in 28mm and 32mm diameters. The 28mm heads are available with short (-3.5mm), medium (0mm) and long (+3.5mm) offsets. The 32mm heads are available with short (-4.0mm), medium (0mm), long (+4mm) and extra long (+7mm) offsets.
The Corin Biolox Delta heads are compatible with Corin titanium stems (i.e. Tri-Fit, Metafix and MiniHip femoral stems having a 12/14 taper trunnion) and the Trinity acetabular system.
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
Prescription Use
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)
Nonclinical testing included burst strength testing on both the 28mm-12/14L and 32mm-12/14XL Biolox delta heads on the Corin titanium taper trunnion to determine the worst case construct. Subsequently, fatigue, post-fatigue burst and pull-off testing were then performed on the worst case construct. The results of the ceramic head testing meet the suggested values in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems." The results of the preclinical data provided indicate that the subject system is within the range of legally marketed predicates.
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
§ 888.3353 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
K103/20
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| 3. 510(K) SUMMARY | ||
|---|---|---|
| 1. Applicant/Sponsor: | Corin USA | |
| 10500 University Center Drive | ||
| Suite 190 | ||
| Tampa, Florida 33612 | ||
| Establishment Registration No.: | FEB 2 8 2011 | |
| 2. Contact Person: | Lucinda Gerber BA (Hons) | |
| Regulatory Affairs Associate | ||
| Corin USA | ||
| 813-977-4469 | ||
| Lucinda.gerber@coringroup.com | ||
| 3. Proprietary Name: | Corin BIOLOX delta Modular Femoral Heads | |
| 4. Common Name: | Femoral Head | |
| 5. Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis (21CFR 888.3353) |
-
- Legally Marketed Devices to which Substantial Equivalence is claimed:
7. Device Description:
BIOLOX delta material is an aluminum oxide / zirconia ceramic composite composed of approximately 75% aluminum oxide and approximately 25% zirconia.
The Corin BIOLOX delta Modular Femoral Heads are available in 28mm and 32mm diameters. The 28mm heads are available with short (-3.5mm), medium (0mm) and long (+3.5mm) offsets. The 32mm heads are available with short (-4.0mm), medium (0mm), long (+4mm) and extra long (+7mm) offsets.
The Corin Biolox Delta heads are compatible with Corin titanium stems (i.e. Tri-Fit, Metafix and MiniHip femoral stems having a 12/14 taper trunnion) and the Trinity acetabular system.
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K103120
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8. Intended Use / Indications:
The Corin BIOLOX delta Modular Femoral Heads are used in combination with femoral hip stems and ultra high molecular weight polyethylene (UHMWPE) acetabular cup liners to reinstate function following the degenerative effects of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular 0 necrosis
- Rheumatoid arthritis 0
- Correction of functional deformity and 0
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) 0
The Corin BIOLOX delta Modular Femoral Heads are intended for single use only.
- Summary of Technologies/Substantial Equivalence: 9.
The Corin Biolox Delta modular femoral heads have the same types of indications and intended uses as the predicates. The technological characteristics are the same as the predicates. Based on the materials, geometry, mechanical testing and indications for use, the Biolox Delta heads are considered to be substantially equivalent to the predicate devices.
10. Non-Clinical Testing:
Nonclinical testing included burst strength testing on both the 28mm-12/14L and 32mm-12/14XL Biolox delta heads on the Corin titanium taper trunnion to determine the worst case construct. Subsequently, fatigue, post-fatigue burst and pull-off testing were then performed on the worst case construct. The results of the ceramic head testing meet the suggested values in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems." The results of the preclinical data provided indicate that the subject system is within the range of legally marketed predicates.
11. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Corin BIOLOX delta Modular Femoral Heads and the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Corin USA % Lucinda Gerber, BA (Hons) Regulatory Affairs Associate 10500 University Center Drive Suite 190 Tampa, Florida 33612
FEB 2 8 2011
Re: K103120
Trade/Device Name: Biolox Delta Modular Femoral Heads 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: LZO Dated: February 09, 2011
Received: February 10, 2011
Dear Ms. Gerber:
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.
3
Page 2 - Lucinda Gerber, BA (Hons)
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 (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
for Dothum ReopDic
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2. INDICATIONS FOR USE
K103120 510{k} Number (if known): _
Device Name: Corin BIOLOX delta Modular Femoral Heads
Indications for Use:
The Corin BIOLOX delta Modular Femoral Heads are used in combination with femoral hip stems and ultra high molecular weight polyethylene (UHMWPE) acetabular cup liners to reinstate function following the degenerative effects of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular ্ necrosis
- Rheumatoid arthritis 0
- Correction of functional deformity and o
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) O
The Corin BIOLOX delta Modular Femoral Heads are intended for 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)
for M. Melkerson
(Division Sign thopedic, Division of Surgical, and Restorative Device
510(k) Number K103120
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