The Series II X3® Large Diameter Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty.

The indications for use of total hip replacement prostheses include:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Device Description

This Special 510(k) submission is a line extension to address modifications made to the Series II X3ª Acetabular Inserts. The modifications made to the previously cleared Series II X3® Acetabular Inserts (K052748) are as follows: new larger head sizes, an alternate 4mm lateralization (with 0 and 10 degree hood), and additional 0 degree hood design to the existing 6mm lateralization.

AI/ML Overview

The provided text describes the Series II X3® Large Diameter Acetabular Inserts and seeks to establish their substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

The document discusses modifications to an existing device (Series II X3® Acetabular Inserts cleared under K052748) to include new larger head sizes, an alternate 4mm lateralization, and an additional 0-degree hood design. The core of the submission is to demonstrate that these modified devices are substantially equivalent to the predicate devices, thereby not requiring a new PMA.

Therefore, there is no specific acceptance criteria or a study proving the device meets those criteria in the sense of a clinical trial or performance evaluation designed to measure specific performance metrics against predefined thresholds. Instead, the "acceptance criteria" here implicitly refers to the FDA's regulatory requirement of demonstrating substantial equivalence to a legally marketed predicate device.

The study that "proves" the device meets this "acceptance criteria" (substantial equivalence) is a summary of non-clinical testing and evaluation.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, there are no explicit acceptance criteria or direct device performance metrics reported in the provided text in the way one might expect from a clinical trial. The "performance" is demonstrated through engineering analysis and comparison to predicate devices to establish substantial equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance / Evaluation
Substantial Equivalence to Predicate Devices	Summary of Non-Clinical Testing and Evaluation (to support substantial equivalence):
- Similar materials	- All devices (subject and predicates) use UHMWPE for the insert component material.
- Similar intended use and indications for use	- Intended use and indications for use are described as essentially identical across the subject device and both predicate devices.
- Similar anatomical placement	- All devices are for Hip - Acetabular Bearing surface.
- Similar sterilization method	- All devices use Gas Plasma sterilization.
- Sufficient mechanical integrity (e.g., locking mechanism, poly thickness) for the new configurations (larger head sizes, lateralization, hood design)	- Preclinical evaluations performed for the new Series II X3® Large Diameter Acetabular Inserts: 1) Poly thickness analysis (Series II X3 and Series II X3 % Large Diameter) 2) Engineering analysis of locking mechanism (Series II X3® and Series II X3® Large Diameter) 3) Engineering analysis of inner diameter, head center, and liner head clearance (Series II X3 ° Large Diameter) - Predicate preclinical testing that was leveraged: 1) Lever Out Testing (Series II X3® and Trident® X3® Large Diameter) 2) Push Out Testing (Series II X3® and Trident® X3® Large Diameter) 3) Evaluation of Wear Characteristics (Trident® X3® Large Diameter)
- No new questions of safety or effectiveness	- The document concludes: "The results of the above testing verify that the new device is substantially equivalent to the predicate device." This implicitly indicates that no new questions of safety or effectiveness were raised.

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

Sample Size: Not specified in terms of number of devices tested. The evaluations were engineering analyses and leveraging of predicate preclinical testing, not a "test set" in the context of human data or a large number of physical units.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given that it's preclinical/engineering analysis, it would be laboratory-based rather than patient-based. These are likely prospective engineering analyses and tests conducted by the manufacturer.

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

Not applicable. This is not a study involving human interpretation of data where ground truth is established by experts (e.g., radiologists). The "ground truth" for engineering analyses would be defined by established engineering and biomechanical principles and accepted test methodologies (e.g., ISO standards for FMEA).

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The outcome of engineering analyses and physical tests is typically objective.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a hip prosthesis, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI performance evaluation was conducted or reported.

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

Not applicable. This is a physical medical device (hip insert), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the engineering analyses and preclinical tests, the "ground truth" would be objective physical measurements, material properties, and adherence to established engineering standards and biomechanical performance expectations applicable to hip prosthesis components. This is verified by the results of the physical and engineering tests themselves rather than external expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI study that involves training data.

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

Not applicable. This is not a machine learning or AI study.

Summary

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KVOZ24 * -My

NCV 1 9 2010

Summary of Safety and Effectiveness Series II X30 Large Diameter Acetabular Inserts

Series II X3® Large Diameter Acetabular Inserts

uncemented prosthesis, 21 CFR §888.3353

prosthesis, 21 CFR §888.3358

Proprietary Name:

Common Name:

Classification Name and Reference:

Regulatory Class:

Product Codes:

Class II

888.3350

Hip prosthesis

87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, nonporous, calcium-phosphate

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous

Hip joint metal/polymer/metal semi-constrained porous coated uncemented

Hip joint metal/polymer semi-constrained cemented prosthesis 21 CFR

87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

87 JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented

Predicate Devices:

Series II X3 Acetabular Inserts and Trident® X3® Acetabular Insert

For Information contact:

Estela Celi, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-6038 estela.celi@stryker.com

Date Prepared:

October 21st, 2010

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Klogl24. *-24

Description

Intended Use

The Series II X3® Large Diameter Acetabular Insert is a sterile, single-use device intended for the replacement of the bearing and/or articulating surfaces of the acetabulum to relieve pain and the restriction of motion.

Indications for Use:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, theumatic 1) arthritis, or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 2)
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve 3) satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated of 4) the acetabulum.

Substantial Equivalence:

The Series II X3º Large Diameter Acetabular Inserts are substantially equivalent to the Series II X3º Acetabular Inserts cleared under K052748 and Trident® X3® Large Diameter Acetabular Inserts cleared under K062419 in regards to intended use, design, materials, and operational principles as a hip prosthesis.

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K108224-#3/4

Substantial Equivalence Table with comparison of Technological Characteristics:

Substantial Equivalence Table with Comparison of Technological Characteristics
Series II Comparison of Subject to Predicate
	Series II X3® LargeDiameter AcetabularInserts	Series II X3®Acetabular Inserts	Trident® X3® Large DiameterAcetabular Insert
510(k)	Pending	K052748	K062419
Product Type	Polyethylene InsertComponents for TotalHip Arthroplasty	Polyethylene InsertComponents for TotalHip Arthroplasty	Polyethylene Insert Componentsfor Total Hip Arthroplasty
Intended Use	Painful, disabling jointdisease of the hipresulting from: non-inflammatorydegenerative arthritis,rheumatoid arthritis,post-traumatic arthritis,or late stage avascularnecrosis; revision ofprevious failed femoralhead replacement, cuparthroplasty or otherprocedure; clinicalmanagement problemswhere arthrodesis oralternativereconstructivetechniques are lesslikely to achievesatisfactory results; andwhere bone stock is ofpoor quality orinadequate for otherreconstructivetechniques as indicatedby deficiencies of theacetabulum.	Painful, disabling jointdisease of the hipresulting from: non-inflammatorydegenerative arthritis,rheumatoid arthritis,post-traumatic arthritis,or late stage avascularnecrosis; revision ofprevious failed femoralhead replacement, cuparthroplasty or otherprocedure; clinicalmanagement problemswhere arthrodesis oralternativereconstructivetechniques are lesslikely to achievesatisfactory results; andwhere bone stock is ofpoor quality orinadequate for otherreconstructivetechniques as indicatedby deficiencies of theacetabulum.	Painful, disabling joint diseaseof the hip resulting from: `non-inflammatory degenerativearthritis, rheumatoid arthritis,post-traumatic arthritis, or latestage avascular necrosis;revision of previous failedfemoral head replacement, cuparthroplasty or other procedure,clinical management problemswhere arthrodesis or alternativereconstructive techniques areless likely to achievesatisfactory results, where bonestock is of poor quality orinadequate for otherreconstructive techniques asindicated by deficiencies of theacetabulum
Anatomical Placement	Hip - AcetabularBearing surface	Hip - AcetabularBearing surface	Hip - Acetabular Bearingsurface
Sizes Standard	0°, 10°26mm to 44mm ID	Similar Hood AngleSimilar Inner Diameter	Similar Hood AngleSimilar Inner Diameter
Sizes Eccentric	0°, 10°4 & 6mm lateralization26mm to 44mm ID	Similar Hood AngleSimilar LateralizationSimilar Inner Diameter	N/A
Compatible AcetabularShells	Secur-Fit, Secur-FitXtra, Omnifit, PSL,Dual Geometry,Microstructured,Osteonics HA Threaded	Secur-Fit, Secur-FitXtra, Omnifit, PSL,Dual Geometry,Microstructured,Osteonics HA Threaded	Trident Hemispherical SolidBack Shells, Trident PSL HASolid Back Shells, TridentHemispherical Cluster Shells,Trident PSL HA Cluster Shells,Trident Hemispherical Multi-Hole Shells
Insert Component Material	UHMWPE	UHMWPE	UHMWPE
Locking Mechanism	Snap-fit mechanism	Snap-fit mechanism	Press-Fit Mechanism
Minimum Nominal Dome	6.43 mm	5.56 mm	3.8 mm
Thickness
Sterilization Method	Gas Plasma	Gas Plasma	Gas Plasma

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K1D312.4 # 4/4

Summary of Non-Clinical Testing and Evaluation:

The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA).The risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices -Application of risk management to medical devices". Records of the risk analysis process are retained in the design history file.

Predicate preclinical testing that was performed:

Lever Out Testing (Series II X3® and Trident® X3® Large Diameter)
Push Out Testing (Series II X3® and Trident® X3® Large Diameter)
Evaluation of Wear Characteristics (Trident® X3® Large Diameter)

Based upon the fact that the new Series II X3% Large Diameter Acetabular Inserts represent a line extent Series II X30 Acetabular Inserts the following preclinical testing/evaluation was preformed:

Preclinical evaluations performed for the new Series II X3® Large Diameter Acetabular Inserts:

1 ) Poly thickness analysis (Series II X3 and Series II X3 % Large Diameter)

Engineering analysis of locking mechanism (Series II X3® and Series II X3® Large Diameter)
Engineering analysis of inner diameter, head center, and liner head clearance (Series II X3 ° Large Diameter)

The results of the above testing verify that the new device is substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its body or wings. The logo is black and white and appears to be a seal or emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Stryker Corporation % Ms. Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430

NOV 1 9 2010

Re: K103124

Trade/Device Name: Series II X3® Acetabular Inserts 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, LZO, MEH Dated: October 21, 2010 Received: October 22, 2010

Dear Ms. Celi:

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 – Ms. Estela Celi

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K10324

NOV 1 9 2010

Device Name: Series II X3® Large Diameter Acetabular Inserts

Indications for Use:

The Series II X30 Large Diameter Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty.

The indications for use of total hip replacement prostheses include:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, l) post-traumatic arthritis, or late stage avascular necrosis.
1. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
1. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by 4) deficiencies of the acetabulum.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Omtu for nxm
(Division Sig Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K103124

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.