(81 days)
No
The summary describes a hip implant system and its components, focusing on material, design modifications, and mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a hip system intended for total or partial hip arthroplasty to treat various degenerative joint diseases and fractures, which falls under the definition of a therapeutic device designed to alleviate or cure a disease or other health condition.
No
This device is described as an implantable hip system intended for total or partial hip arthroplasty, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of metal alloys (Ti-6Al-4V and Co-Cr-Mo) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various hip conditions. This involves direct intervention within the body, not testing samples taken from the body.
- Device Description: The device is described as a hip system (stem and head) made of specific alloys for surgical implantation.
- Performance Studies: The performance studies focus on mechanical properties like fatigue strength and range of motion, which are relevant to a surgical implant, not an IVD.
- 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 summary, the Bencox Hip System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bencox Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed total hip arthroplasty
Product codes (comma separated list FDA assigned to the subject device)
LPH; KWY
Device Description
Bencox II Stem cleared under K103431 is modified at the proximal neck region. The other aspects of design / material / specification / manufacturing & sterilization / packaging are not altered and remain the same as discussed in K103431. The component is manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.
Bencox Metal Head is cleared under K103431 & K112019 with the neck lengths of small, medium and large. This submission includes extra large (XL) neck length as an inclusion to the existing specification. The other aspects of design / material / specification / manufacturing & sterilization/packaging are not altered and remain the same as discussed in K103431 & K112019. The component is manufactured from Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.
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)
The Bencox II Stem neck change & Bencox Metal Head components were subjected to a series of testing protocols to document the performance of the components and to demonstrate substantial equivalence for fatigue strength and range of motion and the included methods are described in the standards, ISO 7206-4, ISO 7206-6 & ISO 21535.
The Bencox Metal Head-XL was also tested with Bencox ID Stem (machined) & Bencox ID Stem (forged). Bencox 11 Stem neck change & Bencox Metal Head-XL components performed either similar or better than the predicate devices cleared under K103431 & K112019.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Special 510(k): Device Modification
K12209
510(K) SUMMARY
Corentec Co., Ltd.
ОСТ 5 2012
r
Bencox II Stem & Bencox Metal Head
July 10th, 2012
ADMINISTRATIVE INFORMATION
Manufacturer Corentec Co., Ltd. 247 Giro-ri, Ipjang-myeon, Seobuk-Gu Cheonan-si, Chungchongnam-do, 331-822 South Korea Telephone: +82-41-585-7114 Fax: +82-41-585-7113
J.S. Daniel Official Contact Project Manager - RA/QA Corentec Co., Ltd 8th Chungho Tower, 748-1 Banpo I Dong Seocho Gu, Seoul, Korea 137-040 Ph: +82 70 4393 3819 Fax: +82 2 3445 5467 Email: jsdaniel@corentec.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Bencox II Stem & Bencox Metal Head |
|---|---|
| Common Name: | Hip Prosthesis |
| Classification Regulations: | 21 CFR 888.3358; 888.3390 |
| Class: | II |
| Product Codes: | LPH; KWY |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
1
Special 510(k): Device Modification
Bencox II Stem & Bencox Metal Head
INTENDED USE
The Bencox Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed total hip arthroplasty
DEVICE DESCRIPTION
Bencox II Stem cleared under K103431 is modified at the proximal neck region. The other aspects of design / material / specification / manufacturing & sterilization / packaging are not altered and remain the same as discussed in K103431. The component is manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.
Bencox Metal Head is cleared under K103431 & K112019 with the neck lengths of small, medium and large. This submission includes extra large (XL) neck length as an inclusion to the existing specification. The other aspects of design / material / specification / manufacturing & sterilization/packaging are not altered and remain the same as discussed in K103431 & K112019. The component is manufactured from Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.
SUBSTANTIAL EQUIVALENCE
The Bencox II Stem & Bencox Metal Head are substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent, as below,
- . Corentec Co., Ltd., Coren Total Hip System (now renamed as Bencox Total Hip System) cleared under K103431
- Corentec Co., Ltd., Bencox Bipolar Cup System cleared under K112019 .
2
Bencox II Stem & Bencox Metal Head
PERFORMANCE DATA
The Bencox II Stem neck change & Bencox Metal Head components were subjected to a series of testing protocols to document the performance of the components and to demonstrate substantial equivalence for fatigue strength and range of motion and the included methods are described in the standards, ISO 7206-4, ISO 7206-6 & ISO 21535.
The Bencox Metal Head-XL was also tested with Bencox ID Stem (machined) & Bencox ID Stem (forged). Bencox 11 Stem neck change & Bencox Metal Head-XL components performed either similar or better than the predicate devices cleared under K103431 & K112019.
STERILIZATION & PACKAGING
Sterilization validation as per ISO 11137 - 1 & 2 Sterilization of health care products - Radiation ensures sterility of the components for an SAL of 106. Both Bencox Il Stem & Bencox Metal Head and the predicate devices cleared under K103431 & K112019 have same shelf life. Following sterilization, packaging was subjected to sterile barrier testing to validate a shelf life of 5 years for both components.
Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. Overall, the Bencox II Stem neck change & Bencox Metal Head-XL has similarities to the predicate devices with the same intended use, same fundamental scientific technology, same operating principles, same materials and are supplied Sterile.
3
Image /page/3/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 stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Corentec Company, Limited % Mr. J.S. Daniel Project Manager - QA/RA 11th Chungho Tower, 748-1 Banpo 1 Dong Seocho Gu, Seoul, Korea 137-040
OCT 5 2012
Re: K122099
Trade/Device Name: Bencox II Stem & Bencox Metal Head Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint metal/polymer/meta1 semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH; KWY Dated: September 4, 2012 Received: September 6, 2012
Dear Mr. Daniel:
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
4
Page 2 - Mr. J.S. Daniel
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erine l. Keith
-> Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K122099
Device Name: Bencox II Stem & Bencox Metal Head
The Bencox Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed total hip arthroplasty
Prescription Use: X (Per 21 CFR 801 Subpart D)
AND / OR
Over-The Counter Use :-(Per 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)
AS~b
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122099