SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS

• K Number: K103124
• Device Name: SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
• Manufacturer: STRYKER CORPORATION
• Date Cleared: 2010-11-19 ( 28 days)
• Product Code: LPH JDI LZO MEH
• Regulation Number: 888.3358

Intended Use

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: 1) Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis. 2) Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3) Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results. 4) 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.

Predicate Devices

K052748, K062419

Reference Devices

K052748

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical implant (acetabular inserts) and its modifications. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on mechanical testing and engineering analysis.

Therapeutic

Yes
The device is an acetabular insert intended for use in total hip arthroplasty to treat painful, disabling joint disease, which directly addresses a medical condition to restore normal function.

Diagnostic

No

Explanation: The device is an acetabular insert for total hip arthroplasty, which is a prosthetic component for treatment, not a device used to diagnose a medical condition. Its intended use is for implantation during surgery to replace a joint, indicated for various types of arthritis and as a revision for previous procedures.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical component (acetabular insert) used in hip replacement surgery, not a software application.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is a component for total hip arthroplasty, which is a surgical procedure performed on a patient's body.
• Device Description: The description details a physical implantable component (acetabular inserts) used in surgery.
• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests.
• Lack of IVD-related information: The document does not mention any testing of biological samples, analysis of bodily fluids, or any other activities associated with in vitro diagnostics.

The device described is a surgical implant used in orthopedic surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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.

Indications for Use:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid 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 of the acetabulum.

Product codes

87 MEH, 87 LZO, 87 LPH, 87 JDI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip - Acetabular Bearing surface
acetabulum

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

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)

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K052748, K062419

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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: [phone] Fax: [phone] [e-mail]

Date Prepared:

October 21st, 2010

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Klogl24. *-24

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.

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:

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.

• 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® Large
Diameter Acetabular
Inserts	Series II X3®
Acetabular Inserts	Trident® X3® Large Diameter
Acetabular Insert
510(k)	Pending	K052748	K062419
Product Type	Polyethylene Insert
Components for Total
Hip Arthroplasty	Polyethylene Insert
Components for Total
Hip Arthroplasty	Polyethylene Insert Components
for Total Hip Arthroplasty
Intended Use	Painful, disabling joint
disease of the hip
resulting from: non-
inflammatory
degenerative arthritis,
rheumatoid arthritis,
post-traumatic arthritis,
or late stage avascular
necrosis; revision of
previous failed femoral
head replacement, cup
arthroplasty or other
procedure; clinical
management problems
where arthrodesis or
alternative
reconstructive
techniques are less
likely to achieve
satisfactory results; and
where bone stock is of
poor quality or
inadequate for other
reconstructive
techniques as indicated
by deficiencies of the
acetabulum.	Painful, disabling joint
disease of the hip
resulting from: non-
inflammatory
degenerative arthritis,
rheumatoid arthritis,
post-traumatic arthritis,
or late stage avascular
necrosis; revision of
previous failed femoral
head replacement, cup
arthroplasty or other
procedure; clinical
management problems
where arthrodesis or
alternative
reconstructive
techniques are less
likely to achieve
satisfactory results; and
where bone stock is of
poor quality or
inadequate for other
reconstructive
techniques as indicated
by deficiencies of the
acetabulum.	Painful, disabling joint disease
of the hip resulting from: `non-
inflammatory degenerative
arthritis, rheumatoid arthritis,
post-traumatic arthritis, or late
stage avascular necrosis;
revision of previous failed
femoral head replacement, cup
arthroplasty or other procedure,
clinical management problems
where arthrodesis or alternative
reconstructive 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
Anatomical Placement	Hip - Acetabular
Bearing surface	Hip - Acetabular
Bearing surface	Hip - Acetabular Bearing
surface
Sizes Standard	0°, 10°
26mm to 44mm ID	Similar Hood Angle
Similar Inner Diameter	Similar Hood Angle
Similar Inner Diameter
Sizes Eccentric	0°, 10°
4 & 6mm lateralization
26mm to 44mm ID	Similar Hood Angle
Similar Lateralization
Similar Inner Diameter	N/A
Compatible Acetabular
Shells	Secur-Fit, Secur-Fit
Xtra, Omnifit, PSL,
Dual Geometry,
Microstructured,
Osteonics HA Threaded	Secur-Fit, Secur-Fit
Xtra, Omnifit, PSL,
Dual Geometry,
Microstructured,
Osteonics HA Threaded	Trident Hemispherical Solid
Back Shells, Trident PSL HA
Solid Back Shells, Trident
Hemispherical 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:

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)

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)

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)

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

4

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

5

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 [phone] or [phone] 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.
• 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• 3. 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