The CS2TM Hip System is 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 tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural. abnormalities

This CS2TM hip stem is indicated for cementless use.

Indications for Use of the CONSENSUS® BIPOLAR or UNIPOLAR:

A. Primary replacement of the femoral head and neck with very little if any acetabular degradation noted.
B. Rheumatoid, osteo, and post traumatic arthritis.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-unions of proximal femoral neck fractures.
F. Revision of failed total hip arthroplasty.
G. Treatment of malunion or nonunion acetabular fractures.

The CONSENSUS® BIPOLAR or UNIPOLAR are intended for cementless use.

Device Description

The Consensus CS2TM Hip System (CS2HS) is a monolithic; titanium alloy fit & fill hip stem design with a proximal, plasma sprayed, porous CPTi coating. The stem has a cylindrical geometry with a bullet tip and is available in sizes designated as 10 mm to 22 mm. The stems feature a neck shaft angle of 128° and a 12/14. Morse taper trumilon. The stems are available with, or without a collar. The CS2 Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is. compatible with previously cleared CoCr heads, zirconia heads, Biolox delta heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.

AI/ML Overview

This 510(k) summary describes a submission for a new hip stem design, the CS2™ Hip System, and primarily focuses on demonstrating its substantial equivalence to previously cleared devices through non-clinical performance data. As such, it does not detail acceptance criteria and a study proving those criteria are met in the same way a clinical trial or a performance study for an AI/ML device would.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like hip stems, "acceptance criteria" are typically related to mechanical properties, material integrity, and biological compatibility, which are demonstrated through bench testing and characterization, not performance metrics like accuracy or AUC. The "reported device performance" refers to the results of these non-clinical tests.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength/Durability (e.g., fatigue resistance)	Bench testing of the new stem design included: - Distal fatigue testing - Proximal fatigue testing of the worst-case stem. These tests were conducted "consistent with the 'Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses'." (The specific quantitative results or pass/fail thresholds are not detailed in this summary.)
Porous Coating Characteristics (e.g., porosity)	CPT plasma sprayed coating characterization "meets the definition of porosity per 21 CFR 888.3358." (Specific quantitative porosity values are not detailed.)
Material Characterization	Based on "material, characterization data, geometry and mechanical testing" (Specific characterization data is not detailed.)
Substantial Equivalence to Predicate Devices	"All of the observed results indicate that the CS2 Hip System is substantially equivalent to devices currently marketed. Therefore, the device is as effective, and performs at least as safely and effectively as legally marketed predicates."

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) summary, as it describes non-clinical bench testing. The "test set" would be the physical samples of the hip stem components subjected to mechanical and material characterization tests. The number of samples for each specific test (e.g., how many stems for fatigue testing) is not specified.
Data Provenance: The data comes from "Non-clinical Performance Data" and "bench testing." This implies internal laboratory testing conducted by Consensus Orthopedics, Inc. (the sponsor). There is no mention of country of origin of the data as it's not patient data, nor is it retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable for this type of submission. Ground truth, in the sense of expert consensus on diagnostic images or clinical outcomes, is not relevant to non-clinical bench testing of a hip implant's mechanical properties. The "ground truth" here is established by engineering standards and regulatory requirements for medical device performance.

4. Adjudication Method for the Test Set

Not applicable as there is no "adjudication" of expert opinions for a test set. Non-clinical tests follow established protocols, and results are measured objectively against predefined engineering specifications or regulatory guidance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists, pathologists) and often for AI/ML-assisted diagnostic tools. This 510(k) pertains to a hip implant's physical and mechanical properties.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone performance study as described is not applicable. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is based on:
- Engineering Standards and Specifications: The mechanical tests (fatigue testing) were conducted "consistent with the 'Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses'." This guidance provides the framework and methodologies for evaluating the safety and effectiveness of such devices.
- Regulatory Definitions: The coating characterization "meets the definition of porosity per 21 CFR 888.3358."
- Essentially, the "ground truth" is adherence to established industry-specific test methods and regulatory requirements for proving the safety and effectiveness of a hip prosthesis.

8. The Sample Size for the Training Set

Not applicable. There is no training set for a physical hip implant. Training sets are typically associated with machine learning algorithms.

9. How the Ground Truth for the Training Set was Established

Not applicable for the reason stated above.

Summary

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K1225/2 Page

Page 1 of 3

2. 510(k) SUMMARY

Sponsor Name:	Consensus Orthopedics, Inc.1115 Windfield Way, Suite 100El.Dorado Hills, CA 95762	NOV 5 2012
510(k) Contact:	Matthew M. Hull, RACPhone: (916) 355-7156/ Fax: (916) 355-7190mhull@consensusortho.com
Date Prepared:	16 August, 2012
Trade Name:	CS2™ Hip System
Common Name:	Porous-coated hip prosthesis for cementless use
Classification Name:	Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis is a Class II device per 21 CFR 888.3358(Product Code LPH).
	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis is a Class II device per 21 CFR888.3353 (Product Code LZO)
	Hip joint, femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis is a Class II device per 21 CFR 888.3353 (Product CodeKWY).

Device Description:

Indications for Use of the CS2TM STEM:

The CS2TM Hip System is 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:

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A. Significantly impaired joints resulting from theumatoid, 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

This CS2TM hip stem is indicated for cementless use.

Indications for Use of the CONSENSUS® BIPOLAR or UNIPOLAR:

A. Primary replacement of the femoral head and neck with very little if any acetabular degradation noted.
B. Rheumatoid, osteo, and post traumatic arthritis.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-unions of proximal femoral neck fractures.
F. Revision of failed total hip arthroplasty.
G. Treatment of malunion or nonunion acetabular fractures.

The CONSENSUS® BIPOLAR or UNIPOLAR are intended for cementless use.

Substantial Equivalence:

Technological Characteristics/ Substantial Equivalence:

The new CS2 femoral stem is substantially equivalent to the stems in the Consensus Hip System (CHS) cleared in 510(k) #K935193 and the stems in the TaperSet Hip System (THS) cleared in. 510(k) #K102399. The CS2HS stem is considered to have the same type of technological characteristics as the CHS stem with regard to the stem geometry and as the THS stem with regard to porous coating. The subject stem is compatible with previously cleared CoCr heads, zirconia heads, Biolox delta heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups. Based on the material, characterization data, geometry and mechanical testing, the CS2 Hip is substantially equivalent to legally marketed predicates.

Legally Marketed Devices to which Substantial Equivalence is claimed:

K102399 (Consensus Orthopedics, Inc.) TARERSET 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

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122512 Page 3/3

K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM

K922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K922560 (U.S. Medical Products) CONSENSUS(TM) BIPOLAR 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 K060635 (Hayes Medical, Inc.) Consensus Total Hip System, Acetabular Cup K030205 (Hayes Medical; Inc.) CONSENSUS UNIPOLAR HEAD. COCR K021466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K020153 (Haves Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW K100933 (Consensus) Consensus Acetabular insert, CS2 Plus K110542 (Consensus) Consensus Biolox delta Ceramic Femoral Heads,

Non-Clinical Performance Data:

Non-clinical testing and analysis were provided, including bench testing and coating characterization. Bench testing of the new stem design included distal fatigue testing and proximal fatigue testing of the worst case stem consistent with the "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses". The CPT plasma sprayed coating characterization meets the definition of porosity per 21 CFR 888.3358.

All of the observed results indicate that the CS2 Hip System is substantially equivalent to devices currently marketed. Therefore, the device is as effective, and performs at least as safely and effectively as legally marketed predicates.

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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 overlapping profiles facing right, representing the department's focus on health, human services, and the well-being of the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Consensus Orthopedics, Incorporated % Mr. Matthew M. Hull, RAC QS, RA Director 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762

5 November 12

Re: K122512 Trade/Device Name: CS2 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, KWY Dated: August 16, 2012 Received: August 20, 2012

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

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Page 2 – Mr. 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 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,

Peter D. Rumm -S

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

Enclosure

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1. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: CS2TM Hip System

Indications for Use of the CS2TM STEM:

The CS21M Hip System is 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 tumorous, . conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

This CS2TM hip stem is indicated for cementless use.

Indications for Use of the CONSENSUS® BIPOLAR or UNIPOLAR:

A. Primary replacement of the femoral head and neck with very little if any acetabular degradation noted.
B. Rheumatoid, osteo, and post traumatic arthritis.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-unions of proximal femoral neck fractures.
F. Revision of failed total hip arthroplasty.
G. Treatment of malunion or nonunion acetabular fractures.

The CONSENSUS® BIPOLAR or UNIPOLAR are intended for cementless use.

Prescription Use	X	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 Division Sign-Off: Device Evaluation (ODE), Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K122512

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.