← Product Code [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH) · K122099 # BENCOX II STEM, BENCOX METAL HEAD (K122099) _Corentec Co., Ltd. · LPH · Oct 5, 2012 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K122099 ## Device Facts - **Applicant:** Corentec Co., Ltd. - **Product Code:** [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH.md) - **Decision Date:** Oct 5, 2012 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3358 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## 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 Story Bencox II Stem and Bencox Metal Head are hip prosthesis components for cementless total or partial hip arthroplasty. Modification includes proximal neck region geometry change for the stem and addition of an extra-large (XL) neck length for the metal head. Components are implanted by orthopedic surgeons during hip replacement surgery to restore joint function and alleviate pain. Device functions as a mechanical replacement for the femoral component of the hip joint. Performance validated via fatigue strength and range of motion testing per ISO 7206-4, ISO 7206-6, and ISO 21535. Sterilized via radiation (ISO 11137-1 & 2) with 5-year shelf life. ## Clinical Evidence Bench testing only. Fatigue strength and range of motion testing performed per ISO 7206-4, ISO 7206-6, and ISO 21535. Results demonstrate performance similar to or better than predicate devices. ## Technological Characteristics Materials: Ti-6Al-4V alloy (ASTM F136) and Co-Cr-Mo alloy (ASTM F1537). Components: Hip prosthesis stem and metal head. Sterilization: Radiation (ISO 11137-1 & 2). Shelf life: 5 years. Connectivity: None (mechanical implant). ## Regulatory 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. ## Predicate Devices - Coren Total Hip System ([K103431](/device/K103431.md)) - Bencox Bipolar Cup System ([K112019](/device/K112019.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K122099](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K122099) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com