(511 days)
No
The device description focuses on the material, design, and mechanical properties of a hip stem, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a femoral hip stem used in total hip arthroplasty to treat various joint diseases and correct functional deformities, which directly addresses medical conditions and restores function.
No
Explanation: The device described is a total hip arthroplasty stem, which is an implant used for joint replacement, not for diagnosing a condition. Its indications for use are for treating existing conditions, not for identifying them.
No
The device description clearly states it is a titanium femoral hip stem, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium, designed to be surgically inserted into the body. This is consistent with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition within the body.
N/A
Intended Use / Indications for Use
The indications for the MiniHip Stem as a total hip arthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and o avascular necrosis
- Rheumatoid arthritis O
- Correction of functional deformity o
- DDH/CDH O
- Revision procedures where other treatments or devices have failed o
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal O femur with head involvement that are unmanageable using other techniques.
The MiniHip Stem is indicated for cementless use only.
Product codes
LZO
Device Description
The MiniHip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAIsV4) alloy and is proximally coated with plasma sprayed hydroxyapatite over plasma sprayed pure titanium in order to enhance primary fixation. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in six sizes, each with the provision of a 130° CCD (Caput-Collum-Diaphysis) neck angle with a polished distal section for guidance and to minimize distal fixation and reduce proximal stress-shielding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral hip, 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, range of motion testing and coating characterization. The results of this testing show that the MiniHip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051738, K080584, K030733, K072417
Reference Device(s)
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
3. 510(K) SUMMARY l. Applicant/Sponsor: Corin USA 10500 University Center Drive Suite 190 Tampa, Florida 33612 Establishment Registration No .: Ashlea Bowen, AA, RAC 2. Contact Person: Regulatory Affairs Associate Corin USA 813-977-4469 ashlea.bowen@coringroup.com 3. Proprietary Name: MiniHip Stem 4. Common Name: Femoral Hip Stem Hip joint metal/ceramic/polymer semi-constrained cemented or 5. Classification Name: nonporous uncemented prosthesis (21CFR 888.3353) Legally Marketed Devices to which Substantial Equivalence is claimed: 6. Howmedica Osteonics Secur-Fit Max Hip and Secure-Fit Plus Max Hip Stems a. (K051738)
- Aesculap Implant Systems Metha Short Stem Hip System (K080584) b.
- Zimmer MAYO Conservative Hip Prosthesis (K030733) C.
- d. Smith & Nephew MIS Hip Stem (K072417)
Device Description: 7.
、
The MiniHip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAIsV4) alloy and is proximally coated with plasma sprayed hydroxyapatite over plasma sprayed pure titanium in order to enhance primary fixation. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in six sizes, each with the provision of a 130° CCD (Caput-Collum-Diaphysis) neck angle with a polished distal section for guidance and to minimize distal fixation and reduce proximal stress-shielding.
-
- Intended Use / Indications:
1
K083312 (pg. 2 of 2)
The indications for the MiniHip Stem as a total hip arthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and o avascular necrosis
- Rheumatoid arthritis O
- Correction of functional deformity o
- DDH/CDH 0
- Revision procedures where other treatments or devices have failed o
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal O femur with head involvement that are unmanageable using other techniques.
The MiniHip Stem is indicated for cementless use only.
-
- Summary of Technologies/Substantial Equivalence:
The MiniHip Stem has the same intended use and indications as the four predicate devices. In addition, the MiniHip Stem is similar in design and available in sizes within the range of the MIS Hip Stem (K072417). The stem is manufactured from the same material and demonstrates similar characteristics as all four predicate devices. The proximal coating of plasma-sprayed HA over plasma-sprayed titanium is the equivalent to that applied to the Secur-Fit Max Hip and Secur-Fit Plus Max Hip Stems (K051738). Based on these similarities, Corin believes that the MiniHip Hip Stem is substantially equivalent to the predicate devices.
- Summary of Technologies/Substantial Equivalence:
-
- Non-Clinical Testing:
Non-clinical testing and analysis included mechanical fatigue testing, range of motion testing and coating characterization. The results of this testing show that the MiniHip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
- Non-Clinical Testing:
11. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Corin U.S.A % Ms. Ashlea Bowen, AA, RAC Regulatory Affairs Associate 10500 University Center Drive, Suite 190 Tampa, Florida 33612
APR - 5 2010
Re: K083312 Trade/Device Name: MiniHip Stem Regulation Number: 21 CFR 8888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: II Product Code: LZO Dated: February 26, 2010 Received: March 1, 2010
Dear Ms. Bowen:
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. Iisting 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 (reporting of medical
3
Page 2 - Ms. Ashlea Bowen, AA, RAC
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 vours.
Mark A. Milliken
Mark N Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2. INDICATIONS FOR USE
510(k) Number (if known): _ KO 83312
Device Name: MiniHip Stem
Indications for Use:
The indications for the MiniHip Stem as a total hip arthroplasty include:
- o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis 0
- Correction of functional deformity o
- DDH/CDH O
- Revision procedures where other treatments or devices have failed ೧
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur 0 with head involvement that are unmanageable using other techniques.
The MiniHip Stem is indicated for cementless 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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K083312
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