The VitalitE Acetabular Insert for the Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications:
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 tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
Acetabular components are indicated for cemented and cementless use.
Consensus femoral stems are indicated for cemented and cementless use.
UniSyn, TaperSet, and CS2 femoral stems are indicated for cementless use only.
HA coated implants are indicated for cementless use only.

Device Description

The Consensus CS2™ Acetabular Cup System consists of a titanium alloy shell (ASTM F620 or F136) and a polyethylene liner (ASTM F648). The system is compatible with the femoral components of all cleared hip systems manufactured by Consensus Orthopedics, Inc.: Consensus Hip System (CHS), TaperSet Hip System (THS), CS2 Hip System (CS2HS), and UniSyn Hip System (UniSyn). The CS2 Acetabular Cup System can be used with the CoCr, zirconia, or Biolox delta femoral heads currently marketed by Consensus and with 22mm, 32mm, and 36mm inner diameters. The liners are available in either neutral or hooded versions and with either standard or lateral offsets. The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The shell comes with or without holes for additional screw fixation. The new acetabular liners will be made from UHMPWE that contains vitamin E (a-tocopherol).

AI/ML Overview

The provided text describes the 510(k) premarket notification for the VitalitE Acetabular Insert for the CS2™ Acetabular Cup System. The submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the VitalitE Acetabular Insert to be evaluated against in a clinical study. Instead, the submission relies on the concept of "substantial equivalence" to predicate devices. The performance data is primarily "Non-Clinical Performance Data."

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Stated as Numerical Criteria)	Reported Device Performance (Summary from Submission)
Material Equivalence	"The vitamin E poly used in the new Consensus CS2 insert is identical to the poly cleared for the StelKast EXp acetabular liner in K094035 and K122773 (with the exception of the radiation dosing level)."	The new VitalitE Acetabular Insert uses a vitamin E cross-linked UHMWPE material that is "identical" to that used in cleared predicate devices (K094035, K122773), with a noted exception in radiation dosing.
Design Equivalence	"The new VitalitE Acetabular Insert for the CS2 Acetabular Cup System is identical in design to the cross-linked UHMWPE acetabular insert previously cleared for Consensus in the following 510(k)s: K021466, K070061, and K100933."	The design of the new insert is "identical" to previously cleared cross-linked UHMWPE acetabular inserts (K021466, K070061, K100933).
Bench Testing Performance	Implied criteria for wear, push-out, and torque-out performance at least as safe and effective as predicates. (Specific numerical criteria not given)	"Non-clinical testing and analysis were provided, including bench testing, material characterization, and biocompatibility testing. Bench testing of the new stem design included wear testing of the worst case acetabular insert, in addition to disassembly testing which included push-out, and torque-out tests." "All of the observed results indicate that the VitalitE Acetabular Insert is substantially equivalent to devices currently marketed."
Biocompatibility	Implied criteria for biocompatibility at least as safe and effective as predicates. (Specific criteria not given)	Biocompatibility testing was performed and included in the overall assessment of substantial equivalence.
Overall Safety & Effectiveness	"as safe, as effective, and performs at least as safely and effectively as legally marketed predicates."	Based on material, characterization data, geometry, and mechanical testing, the device is deemed "substantially equivalent" and thus "as safe, as effective, and performs at least as safely and effectively as legally marketed predicates."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a clinical study with a "test set" of patient data. The "testing" mentioned is entirely non-clinical (bench testing, material characterization, and biocompatibility). Therefore, there is no sample size for a test set or data provenance (country of origin, retrospective/prospective) related to patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Since no clinical study involving patient data was conducted to establish ground truth, no experts were used for this purpose.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a diagnostic device requiring interpretation by human readers. It is a medical implant, and the submission focuses on its physical and material properties.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not a software algorithm device. It is a physical medical device (an acetabular insert).

7. Type of Ground Truth Used:

Ground truth in the typical sense of clinical outcomes or expert consensus for patient data is not used in this submission. The "ground truth" here is established through:

Material properties: Chemical composition and physical characteristics of the UHMWPE.
Design specifications: Geometric and structural adherence to established designs.
Bench test results: Mechanical performance (wear, push-out, torque-out) measured against engineering standards or comparison to predicate device performance under similar test conditions.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was used.

Summary of the Study:

The "study" described in K130652 is a non-clinical substantial equivalence submission. It relies on:

Comparison of material properties: The vitamin E polyethylene is stated to be "identical" to material in already cleared devices.
Comparison of design: The new insert's design is "identical" to previously cleared inserts.
Bench testing: Wear testing of the "worst-case acetabular insert" and disassembly testing (push-out, torque-out) were performed. The results are not detailed but are stated to "indicate that the VitalitE Acetabular Insert is substantially equivalent to devices currently marketed."
Biocompatibility testing: Mentioned as part of the non-clinical data.

The "study" concludes that based on these non-clinical evaluations, the device is "as safe, as effective, and performs at least as safely and effectively as legally marketed predicates." This approach is typical for 510(k) clearances when a new device is fundamentally similar to existing, legally marketed devices.

Summary

{0}------------------------------------------------

K130652

Page 1 of 3

2. 510(k) SUMMARY

DEC 1 7 2013

Sponsor Name:	Consensus Orthopedics, Inc.1115 Windfield Way, Suite 100El Dorado Hills, CA 95762
510(k) Contact:	Matthew M. Hull, RACPhone: (916) 355-7156/ Fax: (916) 355-7190mhull@consensusortho.com
Date Prepared:	16 December, 2013
Trade Name:	VitalitE Acetabular Insert for the CS2™ Acetabular Cup System
Common Name:	Vitamin E Cross Linked Polyethylene, Acetabular Insert
Device Classification:	Class II
Classification(s):	Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis: 21 CFR 888.3358, Product Codes LPH & OQG.
	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis: 21 CFR 888.3353, Product CodesLZO & OQI.
	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis:21 CFR 888.3360, Product Code KWL.
	Hip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis: 21 CFR 888.3390, Product Code KWY.
	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis:21 CFR 888.3360, Product Code LWJ.
	Hip joint metal/polymer semi-constrained cemented prosthesis: 21 CFR888.3350, Product Codes JDI & OQH.

Device Description:

{1}------------------------------------------------

K130652

shell comes with or without holes for additional screw fixation. The new acetabular liners will be made from UHMPWE that contains vitamin E (a-tocopherol).

Indications for Use:

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 tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

Acetabular components are indicated for cemented and cementless use.

Consensus femoral stems are indicated for cemented and cementless use.

UniSyn. TaperSet, and CS2 femoral stems are indicated for cementless use only.

HA coated implants are indicated for cementless use only.

Substantial Equivalence:

Technological Characteristics/ Substantial Equivalence:

The new VitalitE Acetabular Insert for the CS2 Acetabular Cup System is identical in design to the cross-linked UHMWPE acetabular insert previously cleared for Consensus in the following 510(k) s: K021466, K070061, and K100933. The vitamin E poly used in the new Consensus CS2 insert is identical to the poly cleared for the StelKast EXp acetabular liner in K094035 and K122773 (with the exception of the radiation dosing level).

Based on the material, characterization data, geometry and mechanical testing, the new VitalitE CS2 Hip is substantially equivalent to legally marketed predicates.

Legally Marketed Devices to which Substantial Equivalence is claimed:

K100933 (Consensus Orthopedics, Inc.): Consensus CS2 Plus Acetabular Inserts (lateralized) K070061 (Hayes Medical, Inc.): Consensus Hip System 36mm Femoral Head & Acetabular Insert K021466 (Haves Medical, Inc.): Cross Linked Polyethylene Acetabular Insert K122773 (SteKast, Inc.): Cross-Over Acetabular Shell and Liner (lateralized) K094035 (StelKast, Inc.): EXp Acetabular Shell Liner K112802 (Pipeline Orthopedics, Inc.): Pipeline Total Hip System

Non-Clinical Performance Data:

Non-clinical testing and analysis were provided, including bench testing, material characterization, and biocompatibility testing. Bench testing of the new stem design included wear testing of the worst case acetabular insert, in addition to disassembly testing which included push-out, and torque-out tests.

{2}------------------------------------------------

All of the observed results indicate that the VitalitE Acetabular Insert is substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

December 17, 2013

Consensus Orthopedics, Incorporated Matthew M. Hull. RAC Director, Ouality Systems & Regulatory Affairs 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762

Re: K130652

Trade/Device Name: VitalitE Acetabular Insert for the CS2" 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: OQG, LPH, LZO, OQI, KWL, KWY, LWJ, JDI, OQH Dated: November 4, 2013 Received: November 5, 2013

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 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 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

{4}------------------------------------------------

Page 2 -Matthew M. Hull, RAC

forth in the quality systems (OS) 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 vour 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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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 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.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

1. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130652

Device Name: VitalitE Acetabular Insert for the CS2TM Acetabular Cup System

Indications for Use:

The Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications:

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 tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn, TaperSet, and CS2 femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S · 2013.12.13 16:08:40 -05'00'

Division of Orthopedic Devices

Regulation Number and Section

§ 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.