100 - Consensus Orthopedics

1 2. 510(k) SUMMARYP asye I of 3 Sponsor Name: Consensus Orthopedics , Windfield Way, Suite 100El Dorado Hills, CA 95762510(k) Contact: Matthew M. Hull, RACP hone: (916) 355-7156/ Fax: (916) Prepared: 14 August, 2012 Trade Name: TaperSet'F4 H-ip system SmalI StemsCommon Name: Porous-coated hip prosthesis for cenientless useClassification Name: Class HI deviceHip joint metallpolymer/metal semi-constrained porous-coateduncemented prosthesis: 21 CFR , Product Code joint metal/ceramnic/pa lymer semi-constrained cemented ornonporous uncernented prosthesis: 21 CER , ProductCode joint femoral (hemi-hip) metallic cemented or uncementedprosthesis: 21 CFR , Product Code joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis: 21 CFR , Product Code Description.

2 The TaperSet Hip system (THS) is a monolithic, titanium alloy tapered hip stem design witha proximal, plasma sprayed, porous CP Ti coating. The stem has a dual wedge geometry andis available in both standard and 7mm lateral offsets in sizes currently designated as 24mm. The stems feature a neck shaft angle of 1350 and a 12/14 Morse taper trunnion. TheTaperSet flip system is designed for total or partial hip arthroplasty and is intended to beused with compatible components of the Consensus Hip system . The stem is compatiblewith previously cleared CoCr heads, zirconia or Biolox delta ceramic heads, unipolar heads,bipolar heads, UHMWPE inserts and acetabular cups. The modification addressed here is theaddition of two stems in sizes 5mmn and new stems are manufactured from forged titanium alloy (Ti-6A1-4V ELI, ASTM F620)and the proximal portion of the femoral stemn component is plasma sprayed withcommercially pure titanium (C.)

3 P. Ti, ASTM F1I580). The new femnoral stems are availablein both standard and 7mm lateralized options and have the identical neck and taper design,and porous coating as the predicate TaperSet stems cleared under Ki 02399 in design 2 of 3 Indications for Use:The TaperSetim Hip system is designed for total or partial hip axtbroplasty and is intended tobe used with compatible components of the Consensus Hip indications for use are:A. Significantly impaired joints resulting from rheumatoid, osteo, and Revision of failed femoral head replacement, cup arthroplasty or other Proximal femoral Avascular necrosis of the femoral Non-union of proximal femoral neck Other indications such as congenital dysplasia, arthrodesis conversion, caxa magna,caxa plana, coa vara, coxa valga, developmental conditions, metabolic andtumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, andstructural TaperSetTh4 hip stemn is indicated for cementless Equivalenc e:Technological CA aracleristiks/Substantial new smaller stems for the TaperSet Hip system have the same design, porous coating,and indications as the predicate TaperSet stems cleared under KI 02399.

4 Taper style femoralstems in sizes 5 Sand 6mmn were previously cleared by FDA under K103755 for the BiometTaperloc complete Hip system extension. The subject Consensus stemns are still compatiblewith previously cleared Co~r heads, zirconia and Biolox delta ceramic heads, unipolar heads,bipolar heads, UHMWPE inserts and acetabular cups. Based on the material, characterizationdata, and geometry, the TaperSet Hip small stems are substantially equivalent to the legallymarketed Performance Data:The TaperSet small stems are identical to the predicate TaperSet stems cleared underK102399 in design, materials, packaging, and indications, the two new stems (5 & 6 mm)are just smaller in overall dimensions and thus created a new worst-case 5mm lateral femoral stem was determined to be the worst-case example per analysisreport (R 1-007).

5 The stems were to achieve 5 million cycles of loading at a maximum loadof 517 lbs. (2300 N) without failure in accordance with ASTM F2068-2009 and ISO 7206-4:2010O(E).2 Pany 3 of 3 Based upon engineering analysis and testing of the design modification the new 5 & 6 mmfemoral stems for the TaperSet Hip system by Consensus are substantially equivalent todevices currently marketed. Therefore, the device is as safe, as effective, and performs atleast as safely and efi-ectively as the legally marketed OFHAT UA EVCSP ublic Health ServiceFood and Drug Administration10903 New Hampshire AvenueDocument Control Room -W066-G609 Silver Spring, MD 20993-0002 Consensus Orthopedics , IncorporatedSp% Mr. Matthew M. Hull, RAC 70"Director, QS & RA 201?1115 Windfield Way, Suite 100El Dorado Hills, California : K121935 Trade/Device Name: TaperSet Hip system Small StemsRegulation Number: 21 CFR Name: Hip joint metal/polymer/metal semi-constrained porous-coat-eduncemented prosthesisRegulatory Class: Class 11 Product Code: LPH, LZO, KWL, KWYD ated: August 14, 2012 Received: August 15, 2012 Dear Mr.

6 Hull:We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.

7 Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you; however, that device labeling must be truthful and not your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies.

8 You mustPage 2 -Mr. Matthew M. Hull, RACcomply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 80 1); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 21 CFR you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasego to ~Office/ucm forthe Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, pleasenote the regulation entitled, "Misbranding by reference to premarket notification" (21 ICFR ).

9 For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go tohtp://www~ for the CDRH' s Officeof Surveillance and Biometrics/Division of Postmarket may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet yours,Mark N. Melkerson 0 DirectorDivision of Surgical, Orthopedicand Restorative DevicesOffice of Device EvaluationCenter for Devices andRadiological HealthEnclosure1. INDICATIONS FOR USE STATEMENT510(k) Number (if known): 1RD /. a/?&Device Name: TaperSetTh Hip system Small StemsIndications for Use:The TaperSetTM Hip system is designed for total or partial hip arthroplasty and is intended tobe used with compatible components of the Consensus Hip Significantly impaired joints resulting from rheumatoid, ostec, and post-traumatic Revision of failed femoral head replacement, cup artbroplasty or other hip Proximal femoral Avascular necrosis of the femoral Non-union of proximal femoral neck Other indications such as congenital dysplasia, arthrodesis conversion, con nmagna, coxaPlana, cona vara, coxa valga, developmental conditions, metabolic and tumorous conditions,osteomalacia, osteoporosis, pseudarthrosis conversion.

10 And structural TaperSetTm hip stem is indicated for cementless Use X AND/OR Over the Counter Use __(21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)(Dvtin Sin-OfliDivision of Surgical' Orthopedic,and Restorative Devices510(k)Nuinber KI Is)