← Product Code [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH) · K130149 # U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE (K130149) _United Orthopedic Corporation · LPH · Jun 6, 2013 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K130149 ## Device Facts - **Applicant:** United Orthopedic Corporation - **Product Code:** [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH.md) - **Decision Date:** Jun 6, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3358 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - Inflammatory degenerative joint disease such as rheumatoid arthritis; - Correction of function deformity; - Revision procedures where other treatments or devices have failed; - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques. This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only. ## Device Story U2 Hip System is a total hip prosthesis consisting of femoral and acetabular components. It is a single-use implant intended for surgical implantation by orthopedic surgeons in a hospital setting. The system is designed for cementless use, with the exception of specific stems designed for cemented use. The device functions as a mechanical replacement for the hip joint to restore function and reduce pain. This submission serves to unify and expand the indications for use across several previously cleared U2 and U1 hip system components. No changes were made to the device design, materials, or manufacturing processes. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on the identical technological characteristics to previously cleared predicate devices. ## Technological Characteristics Total hip prosthesis (metal/polymer/metal semi-constrained porous-coated uncemented). Components include femoral stems, acetabular cups, and femoral heads. Materials, design, and sterilization methods are identical to predicate devices. No software or electronic components. ## 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 - UNITED U1 Hip System ([K994078](/device/K994078.md)) - UNITED U2 Hip Stem, Ti porous coated ([K003237](/device/K003237.md)) - UNITED U2 Acetabular Cup and Femoral Head ([K022520](/device/K022520.md)) - UNITED U2 Acetabular Component ([K050262](/device/K050262.md)) - UNITED U2 Hip Stem, Ti Plasma Spray ([K062978](/device/K062978.md)) - UNITED U2 Hip System ([K111546](/device/K111546.md)) - UNITED U2 Acetabular Cup, Plasma Spray ([K121777](/device/K121777.md)) - UNITED Femoral Heads, +2.5 & +7.5 mm Offset ([K122504](/device/K122504.md)) ## Reference Devices - WRIGHT STEM Hip Replacement System ([K021346](/device/K021346.md)) - HOWMEDICA Stryker Modular Hip System ([K071082](/device/K071082.md)) - BIOMET Medallion Modular Hip System ([K041850](/device/K041850.md)) - UNITED U1 Hip System-Bipolar ([K050269](/device/K050269.md)) - UNITED U2 Bipolar Implant ([K101670](/device/K101670.md)) - Smith & Nephew Global Bipolar System ([K023743](/device/K023743.md)) - BIOMET RingLoc Bi-Polar Acetabular Component ([K051569](/device/K051569.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}------------------------------------------------ K130149 (pg 1/4) ഗ്ര U2 Hip System, Expanded Indications for Use 510(k) Summary # 510(k) Summary of Safety and Effectiveness | Submitted by: | United Orthopedic Corporation | | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Address: | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan | | | Phone Number: | +886-3-5773351 ext. 2212 | | | Fax Number: | +886-3-577156 | | | Date of Summary: | January 16, 2013 | | | Contact Person: | Fang-Yuan Ho | | | | Manager, Regulatory Affairs | | | Proprietary Name: | U2 Hip System, Expanded Indications for Use | | | Common Name: | Total hip prostheses | | | Device Classification Name and Reference: | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis under 21CFR 888.3358
This falls under the Orthopedics panel. | | | Device Class | Class II | | | Panel Code | Orthopaedics Device | | | Device Product Code: | LPH, JDI, MEH | | | Predicate Device: | 1. "UNITED" U1 Hip System (K994078) | | | | 2. "UNITED" U2 Hip Stem, Ti porous coated (K003237) | | | | 3. "UNITED" U2 Acetabular Cup and Femoral Head (K022520) | | | | 4. "UNITED" U2 Acetabular Component (K050262) | | | | 5. "UNITED" U2 Hip Stem, Ti Plasma Spray (K062978) | | | | 6. "UNITED" U2 Hip System (K111546) | | | | 7. "UNITED" U2 Acetabular Cup, Plasma Spray (K121777) | | | | 8. "UNITED" Femoral Heads, +2.5 & +7.5 mm Offset (K122504) | | UOC-FDA-026 Page: Summary-1/4 {1}------------------------------------------------ #### ਹ U2 Hip System, Expanded Indications for Use ### Device Description: There are two purposes in current submission, the fist one is to expand the Indications for Use of two cleared products: U2 Hip System (K111546) and Femoral Heads, +2.5 & +7.5 mm Offset (K122504), which have been expanded to a population with similar demographic, diagnosis and prognosis as the original. The second purpose of this submission is to reword the statement of Indications for Use of six cleared "UNITED" hip products including U1 Hip System (K994078), U2 Hip Stem, Ti porous coated (K003237), U2 Acetabular Cup and Femoral Head (K022520), U2 Acetabular Component (K050262), U2 Hip Stem and Ti Plasma Spray (K062978) and U2 Acetabular Cup, Plasma Spray (K121777). Through this submission, the Indications for Use of above listed devices are unified as one version, and the components, materials, design, processing methods, sterilization methods, biocompatibility, safety and effectiveness of above listed devices are unchanged by this submission. ## Indications for Use: This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - Non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - Inflammatory degenerative joint disease such as rheumatoid arthritis; 2. - Correction of function deformity; 3. - · 4. Revision procedures where other treatments or devices have failed; - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement that is unmanageable using other techniques. This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only. UOC-FDA-026 Page: Summary-2/4 {2}------------------------------------------------ #### (ਗੋ U2 Hip System, Expanded Indications for Use 510(k) Summary ## Basis for Substantial Equivalence: The components, design, materials, packaging materials and sterilization method of U2 Hip System- Expanded Indications for Use are identical to cleared predicate devices: 1. "UNITED" U1 Hip System (K994078) 2. "UNITED" U2 Hip Stem, Ti porous coated (K003237) 3. "UNITED" U2 Acetabular Cup and Femoral Head (K022520) 4. "UNITED" U2 Acetabular Component (K050262) 5. "UNITED" U2 Hip Stem, Ti Plasma Spray (K062978) 6. "UNITED" U2 Hip System (K111546) 7. "UNITED" U2 Acetabular Cup, Plasma Spray (K121777) 8. "UNITED" Femoral Heads, +2.5 & +7.5 mm Offset (K122504) The only difference between the proposed and predicate devices is the integration of Indications for Use. The submitted indications are substantially equivalent to the predicate products and do not affect the functional effectiveness and safety. Besides, the indications are substantially equivalent to legally marketed "WRIGHT" STEM Hip Replacement System (K021346), "HOWMEDICA" Stryker Modular Hip System (K071082) and "BIOMET" Medallion Modular Hip System (K041850) for total hip replacement. In the other hand, for bipolar hip replacement, the indications of current submission are identical to "UNITED" U1 Hip System-Bipolar (K050269) and "UNITED" U2 Bipolar Implant (K101670), and are also equivalent to "Smith & Nephew" Global Bipolar System (K023743) and "BIOMET" RingLoc® Bi-Polar Acetabular Component (K051569). ## Summary of Technologies The technological characteristics (design, materials, packaging materials and sterilization method) of the U2 Hip System- Expanded Indications for Use are identical Page: Summary-3/4 {3}------------------------------------------------ #### ക U2 Hip System, Expanded Indications for Use 510(k) Summary to the predicate products. ## Non-Clinical Testing Non-clinical laboratory testing is not provided as a basis for substantial equivalence. ## Clinical Testing None provided as a basis for substantial equivalence. UOC-FDA-026 Page: Summary-4/4 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 6. 2013 United Orthopedic Corporation % Fang-Yuan Ho Regulatory Affairs. Manager No. 57. Park Avenue 2, Science Park Hsinchu 300 Taiwan Re: K130149 Trade/Device Name: U2 Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI. MEH Dated: March 8, 2013 Received: March 13, 2013 Dear Fang-Yuan Ho: 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 {5}------------------------------------------------ Page 2 – Fang-Yuan Ho 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. ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address. 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, Erin Keith | For | Mark N. Melkerson | |-----|---------------------------------| | | Director | | | Division.of.Orthopedic.Devices. | | | Office of Device Evaluation | | | Center for Devices and | | | Radiological Health | Enclosure {6}------------------------------------------------ # Indication for Use K130149 (pg 1/1) 510 (k) Number (if known): Device Name: U2 Hip System, Expanded Indications for Use ## Indications for Use: This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - 2. Inflammatory degenerative joint disease such as rheumatoid arthritis; - 3. Correction of function deformity; - 4. Revision procedures where other treatments or devices have failed; - 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques. This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented 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) Elizabeth Frank -S Division of Orthopedic Devices Page I of I --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K130149](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K130149) **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. 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