CS2 MULTI-HOLE ACETABULAR SHELL

K141043 · Consensus Orthopedics, Inc. · LPH · May 19, 2014 · Orthopedic

Device Facts

Record IDK141043
Device NameCS2 MULTI-HOLE ACETABULAR SHELL
ApplicantConsensus Orthopedics, Inc.
Product CodeLPH · Orthopedic
Decision DateMay 19, 2014
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3358
Device ClassClass 2
AttributesTherapeutic

Intended Use

The CS2™ Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, CS2™ HIP SYSTEM, and the TAPERSET™ HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS® HIP SYSTEM. The indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. B. - C. Proximal femoral fractures. - D. Avascular necrosis of the femoral head. - Non-union of proximal femoral neck fractures. - F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2™ and TAPERSET™ hip stems are indicated for cementless use. The UNISYN™ HIP SYSTEM is indicated for significantly impaired joints resulting from theumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. - A. Proximal femoral fractures. - B. Avascular necrosis of the femoral head. - C. Non-union of proximal femoral neck fractures. - D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. UNISYN™ stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN™ stems used with plasma/HA or HA coated bodies are intended for uncemented use only.

Device Story

Acetabular shell component for total or partial hip arthroplasty; used in conjunction with mating inserts and optional bone screws for fixation. Device features hemispherical or flared rim designs with up to 10 screw holes for bone screw placement to augment initial fixation. Manufactured from titanium alloy with porous titanium bead coating. Insert options include UHMWPE or highly cross-linked polyethylene. Used by orthopedic surgeons in clinical settings. Provides mechanical support and articulation surface for hip joint replacement; screw holes allow surgeon to tailor fixation based on patient bone quality.

Clinical Evidence

No clinical data. Bench testing only; engineering design evaluation determined that the addition of screw holes did not necessitate further biomechanical testing.

Technological Characteristics

Acetabular shell: Titanium alloy (Ti 6Al-4V ELI, ASTM F620/F136) with porous CP Ti bead coating (ASTM F-67). Inserts: UHMWPE (ASTM F648) or highly cross-linked polyethylene (ASTM F2695). Bone screws: Wrought titanium alloy (Ti 6Al-4V ELI, ASTM F136). Features circumferential scallops for rotational security and optional apical dome hole plug/cement pod spacer. Non-software device.

Indications for Use

Indicated for patients with significantly impaired hip joints due to rheumatoid, osteoarthritis, or post-traumatic arthritis; revision of failed hip procedures; proximal femoral fractures; avascular necrosis; non-union of femoral neck fractures; congenital dysplasia; arthrodesis conversion; metabolic/tumorous conditions; osteomalacia; osteoporosis; pseudarthrosis; and structural abnormalities.

Regulatory Classification

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ MAY 1 9 2014 K141043 Page 1 of 4 # 2. 510(k)SUMMARY | Sponsor Name: | Consensus Orthopedics, Inc.<br>1115 Windfield Way, Suite 100<br>El Dorado Hills, CA 95762 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Contact: | Matthew M. Hull, RAC<br>Phone: (916) 355-7156/ Fax: (916) 355-7190<br>mhull@consensusortho.com | | Date Prepared: | 21 April 2014 | | Trade Name: | Multi-Holed Shell for use with the CS2TM Acetabular Cup<br>System | | Common Name: | Acetabular Shell | | Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis (21 CFR 888.3358, Product Code LPH)<br><br>Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (21 CFR 888.3353, Product<br>Code LZO) | | Regulatory Class: | Class II | Device Classification Panel: Orthopedic Devices ### Device Description: The CS2 Acetabular Cup System consists of a shell and a mating insert. The acetabular component is designed for cemented or uncemented use. The acetabular shell is manufactured from titanium alloy (Ti 6Al-4V ELI, ASTM F620 or ASTM F136), with a porous coating of commercially pure titanium beads (CP Ti ASTM F-67). The acetabular shells are available with or without screw holes in hemispherical or flared rim versions. The component has matching circumferential scallops on the shell and insert that rotationally secure the insert in the shell and allow for dialing the insert in a desired orientation. The shells with screw holes have up to 10 anatomically placed holes which accommodate optional bone screws to augment initial fixation. An optional apical dome hole plug and cement pod spacer are available. The acetabular insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648); highly cross linked polyethylene (UHMWPE, ASTM F648), or VitalitE (UHMWPE, ASTM F2695). They all feature a titanium alloy X-ray marker (Ti 6Al-4V ELI, ASTM F136). {1}------------------------------------------------ The cancellous bone screws are manufactured from wrought titanium alloy (Ti 6Al-4V ELI. ASTM F136). The cancellous bone screws are 6.5mm diameter and have a low profile head with a hex drive recess. These are provided with certain versions of the acetabular shell for the option of additional fixation. ### Indications for Use: The CS2TM Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, CS2 ™ HIP SYSTEM, and the TAPERSET™ HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS® HIP SYSTEM. The indications for use are: - A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. - C. Proximal femoral fractures. - D. Avascular necrosis of the femoral head. - E. Non-union of proximal femoral neck fractures. - F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and turnorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2TM and TAPERSET™ hip stems are indicated for cementless use. The UNISYN™ HIP SYSTEM is indicated for significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. - A. Proximal femoral fractures. - B. Avascular necrosis of the femoral head. - C. Non-union of proximal femoral neck fractures. - D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. UNIS YN™ stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN™ stems used with plasma/HA or HA coated bodies are intended for uncemented use only. {2}------------------------------------------------ # Substantial Equivalence: # Technological Characteristics/ Substantial Equivalence: The intended use, materials, and design features of the subject Multi-Hole Shell for use with the CS2™ Acetabular Cup System are substantially equivalent to those of predicate devices manufactured by Consensus Orthopedics (Table 9.1). Previously cleared versions of the acetabular shell had from 3 to 5 screw holes, the new Multi-hole shell will offer options up to 10 screw holes. The safety and effectiveness of the Multi-hole Shell are adequately supported by the substantial equivalence information and materials data provided within this 510(k) submission. # Table 9.1: Predicate device summary table. | 510(k)<br>Number | Trade Name | 510(k) holder | 510(k) Clearance<br>Date | |------------------|-----------------------------------|-----------------------------|--------------------------| | K922561 | Consensus™ Total Hip System | Consensus Orthopedics, Inc. | 07/21/1993 | | K060635 | Consensus Acetabular Shell System | Consensus Orthopedics, Inc. | 04/28/2006 | # Legally Marketed Devices which are compatible: K102399 (Consensus Orthopedics, Inc.) TAPERSET HIP SYSTEM K030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM K935193 (U.S. Medical Products) Consensus' Hip System - Porous Coated Titanium Femoral Stem K935453 (U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUM FEMORAL STEM K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-PORQUS TITANIUM FEMORAL STEM K922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K070061 (Hayes Medical, Inc.) Consensus Hip System 36 mm CoCr Femoral Head K953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5. 0. +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K960339 (U.S. Medical Products) CONSENSUS 22MM COCRMO FEMORAL HEAD K960156 (U.S. Medical Products) CONSENSUS 32MM COCRMO FEMORAL HEAD K960151(U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD K021466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K953198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW K953198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW K100933 (Consensus) Consensus Acetabular insert. CS2 Plus K110542 (Consensus) Consensus Biolox delta Ceramic Femoral Heads K121263 (Consensus) TaperSet Hip System RDP Stem K121935 (Consensus) TaperSet Hip System Small Stems K120595 (Consensus) UniSyn Plus Hip Stem K122512 (Consensus) CS2 Hip Stem K130652 (Consensus) VitalitE Acetabular Insert {3}------------------------------------------------ # Non-Clinical Performance Data: Engineering design evaluation of the additional screw holes being added to the acetabular shell shows that no additional biomechanical testing was required {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 19, 2014 Consensus Orthopedics, Inc. Mr. Matthew M. Hull QS & RA Director 1115 Windfield Way El Dorado Hills. California 95762 Re: K141043 Trade/Device Name: Multi-Hole Acetabular Shell for the CS2"14 Acetabular Cup 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, LZO Dated: April 21, 2014 Received: April 23, 2014 Dear Mr. Hull: 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 cither 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 {5}------------------------------------------------ Page 2 - Mr. Matthew M. Hull 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, # Lori A. Wiqqins for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### 1. INDICATIONS FOR USE STATEMENT # 510(k) Number (if known): K141043 #### Device Name: Multi-Hole Acetabular Shell for the CS27M Acetabular Cup System #### Indications for Use: The CS2™ Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, CS2™ HIP SYSTEM, and the TAPERSET™ HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS® HIP SYSTEM. The indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. B. - C. Proximal femoral fractures. - D. Avascular necrosis of the femoral head. - Non-union of proximal femoral neck fractures. ﻨﻨﺎ - F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2™ and TAPERSET™ hip stems are indicated for cementless use. The UNISYN™ HIP SYSTEM is indicated for significantly impaired joints resulting from theumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. - A. Proximal femoral fractures. - B. Avascular necrosis of the femoral head. - C. Non-union of proximal femoral neck fractures. - D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. UNISYN™ stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN™ stems used with plasma/HA or HA coated bodies are intended for uncemented use only. Prescription Use X (21 CFR Part 801 Subpart D) AND/OR Over the Counter Use (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) # Elizabethí@Ærank -S Division of Orthopedic Devices
Innolitics
510(k) Summary
Decision Summary
Classification Order
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