CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ

• K Number: K990330
• Device Name: CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ
• Manufacturer: IMPLEX CORP.
• Date Cleared: 2000-03-01 ( 393 days)
• Product Code: JDI
• Regulation Number: 888.3350
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K944883 , K930107 , K930438 , K971911 , K020815 , K003310
• Predicate For: N/A

Intended Use

The Implex Cross-Linked Polyethylene Acetabular Components are intended to be used with the below listed, legally marketed Implex Acetabular Component Replacement Systems to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads:

1. The Implex HEP (Hedrocel) Acetabular Cup, cemented & cernentless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
2. The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
3. The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10 ° and 20° face angle options.
4. The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.

Device Description

Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads:

1. The Implex HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
2. The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
3. The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10° and 20° face angle options.
4. The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.

The raw material being utilized in the manufacture of both the subject and predicate devices remains as direct and sheet compression molded ultrahigh molecular weight polyethylene (UHMWPE) conforming to ASTM F-648. The modifications to the manufacturing process of this polyethylene will be introduced to create a higher cross-linked polyethylene.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for Implex Cross-Linked Polyethylene Acetabular Components, focusing on wear claims. It does not describe a medical device that uses AI or goes through typical clinical study acceptance criteria as might be expected for software-based diagnostic devices. Instead, it concerns the physical properties of a medical implant and its performance in in-vitro testing.

Therefore, many of the requested categories for AI/software-based devices (like test set size, expert ground truth, MRMC study, training set, etc.) are not applicable to this submission. I will address the relevant information that can be extracted.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Wear Rate Reduction:
Sheet Compression Molded GUR 1020:
- Demonstrates significant wear rate reduction compared to current Implex sheet compression molded GUR 1020 polyethylene.	65% reduction in gravimetric wear rate vs. current Implex sheet compression molded GUR 1020 polyethylene (28 mm/52 mm ID/OD, 9.5 mm thickness).
- Demonstrates significant wear rate reduction compared to Charnley 'Gold Standard' (22 mm heads).	47% less than the Charnley 'Gold Standard' (22 mm heads).
- Demonstrates significant wear rate reduction compared to Charnley 'Gold Standard' (28 mm heads).	87% less than the Charnley 'Gold Standard' (28 mm heads) (0.1 mm of linear head penetration converted to volumetric wear).
Direct Compression Molded (DCM) GUR 1020:
- Demonstrates significant wear rate reduction compared to current Implex direct compression molded GUR 1020 polyethylene.	89% reduction in gravimetric wear rate vs. current Implex direct compression molded GUR 1020 polyethylene.
- Demonstrates significant wear rate reduction compared to Charnley 'Gold Standard' (22 mm heads).	67% less than the Charnley 'Gold Standard' (22 mm heads).
- Demonstrates significant wear rate reduction compared to Charnley 'Gold Standard' (28 mm heads).	95% less than the Charnley 'Gold Standard' (28 mm heads) (linear head penetration converted to volumetric wear).
Substantial Equivalence:	Demonstrated substantial equivalence to identified predicate devices regarding intended use, indications, contraindications, design specifications, and raw material (DCM and sheet compression molded UHMWPE conforming to ASTM F-648), with modifications to manufacturing process to create a higher cross-linked polyethylene. Safety and effectiveness supported by provided information, materials data, and testing results.

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

• Test Set: The "test set" in this context refers to the physical samples of the acetabular components undergoing wear simulation.
  • Sample Size: Not explicitly stated as a number of individual components. The text mentions "the same acetabular components (28 mm/52 mm ID/OD, with polyethylene thickness of 9.5 mm)" for sheet compression molded and "polyethylene thickness was 8.2 mm for the tested DCM components." It implies that specific configurations were tested. A specific count of components tested is not provided, which is common for material testing.
  • Data Provenance: The testing was "in-vitro hip wear simulation testing." It's laboratory-based, not patient-derived or country-specific in the sense of clinical data.

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

• Not Applicable. For mechanical wear testing of an implant, the "ground truth" is established by the physical testing methodology itself (e.g., gravimetric wear rate measurements) and adherence to established standards (e.g., use of ASTM F-648 for UHMWPE). This does not involve human expert consensus or interpretation of data in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human experts (e.g., in image interpretation). This is a physical, objective test.

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 is a hardware implant, not an AI diagnostic device. No human readers or AI assistance are involved in interpreting the wear test results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a hardware implant. The "standalone performance" is its physical wear characteristics during the in-vitro simulation.

7. The Type of Ground Truth Used

• Objective Physical Measurement / Performance Standard. The ground truth for the wear claims is based on:
  • Gravimetric wear rate measurements from in-vitro hip wear simulation tests.
  • Comparison to specified "current" Implex products and the "Charnley 'Gold Standard'" (a benchmark for hip prostheses).
  • Material conformity to ASTM F-648.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device; there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study:

The study proving the device meets the acceptance criteria (primarily concerning reduced wear) was an in-vitro hip wear simulation testing performed under multiaxial hip joint simulation for 5 million cycles.

• Conditions:
  • Femoral Head: Super-finished Implex 28 mm Co-Cr-Mo femoral head.
  • Acetabular Component: Corresponding to a shell OD of 52 mm.
  • Lubricant: Bovine calf serum.
  • Cycle Count: 5 million cycles.
  • Polyethylene Thickness: 9.5 mm for sheet compression molded components; 8.2 mm for direct compression molded (DCM) components.

The results showed significant reductions in gravimetric wear rates for both sheet compression molded and direct compression molded cross-linked polyethylene compared to existing Implex products and the Charnley 'Gold Standard'. The manufacturer explicitly states a disclaimer: "The results of such in-vitro hip wear simulation tests have not been shown to correlate with clinical wear mechanisms." This is an important caveat regarding the interpretation of these in-vitro results.

Summary

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

K990330

Implex Corp.

MAR - 1 2000

Cross-Linked Polyethylene Acetabular Components Supplement #3 to K990330

pg 1 of 3

510(k) SUMMARY - Implex Cross-Linked Polyethylene Acetabular Components

• Implex Corp. Submitter Name: Submitter Address: 80 Commerce Drive Allendale, New Jersey 07401-1600 Contact Person(s): Robert Poggie or John Schalago [phone] Phone Number: [phone] Fax Number: February 28, 2000 Date Prepared: Implex Cross-Linked Polyethylene Acetabular Device Trade Name: Components Device Common Name: Polyethylene Acetabular Components Classification Name: Prosthesis, Hip, Acetabular Component, Cemented, Cementless Predicate Devices: Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices: 1) The Implex HEP (Hedrocel) Acetabular Cup, cemented & cementless 2) The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless 3) The Implex A-230 (beaded) Acetabular Cup System, cemented & cementless The Implex Modular Elliptical Porous Cup System 5) The DePuy Duraloc Acetabular Cup System
  • 6) Osteonics Cross-Fire Acetabular Components

1

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K99 0330

510(k) Summary, Continued

Device Description:

Intended Use:

Wear Claims:

Implex Cross-Linked Polyethylene Acetabular
Components are for use with the following legally
marketed Implex devices with 28 mm femoral heads:

1. The Implex HEP (Hedrocel) Acetabular Cup, cemented
   & cementless. The permitted OD size is 52 mm and
   greater for the 0° face-angle, and OD sizes 50 mm and
   greater for the 10 and 20° face-angle options.
2. The Implex Revision HEP (Hedrocel) Acetabular Cup,
   cemented & cementless. The permitted OD size is 52
   mm and greater for the 0° face-angle, and OD sizes 50
   mm and greater for the 10 and 20° face-angle options.
3. The Implex A-230 (porous beads) Acetabular Cup
   System, cemented & cementless. The permitted OD size
   is 52 mm and greater for the 0°, 10° and 20° face angle
   options.
4. The Implex Modular Elliptical Porous Cup. The
   permitted OD size is 54 mm and greater for the 0°, 10°
   and 20° face angle options.

The Implex Cross-Linked Polyethylene Acetabular
Components are intended to be used with the above
listed, legally marketed Implex Acetabular Component
Replacement Systems to resurface the acetabular socket
in cemented or cementless total hip arthroplasty.

Implex Cross-Linked Polyethylene Acetabular
Components with sheet compression molded GUR
1020 show a 65% reduction in gravimetric wear rate
versus the same acetabular components (28 mm/52
mm ID/OD, with polyethylene thickness of 9.5 mm)
fabricated from Implex's current sheet compression
molded GUR 1020 polyethylene, 47% less than the
Charnley 'Gold Standard' (22 mm heads), and 87% less
than the Charnley 'Gold Standard' 28 mm heads), (0.1
mm of linear head penetration converted to volumetric
wear).

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

Wear Claims:

Pag Sog 3 Cross-Linked Polyethylene Acetabular Implex Components with direct compression molded (DCM) GUR 1020 show a 89 % reduction in gravimetric wear rate versus the same acetabular components fabricated from Implex's current direct compression molded GUR 1020 polyethylene, 67 % less than the Charnley 'Gold Standard' (22 mm heads), and 95 % less than the linear head penetration converted to volumetric wear).

All hip wear simulation testing was performed under multiaxial hip joint simulation for 5 million cycles, using a super-finished Implex 28 mm Co-Cr-Mo femoral head articulating counterface, a polyethylene component corresponding to a shell OD of 52 mm, and with bovine calf serum as a lubricant. Polyethylene thickness was 8.2 mm for the tested DCM components.

The results of such in-vitro hip wear simulation tests have not been shown to correlate with clinical wear mechanisms.

The intended use, indications, contraindications, and design specifications of the subject components remain the same as their Implex predicate component counterparts, for the acetabular components and sizes listed above. The raw material being utilized in the manufacture of both the subject and predicate devices remains as direct and sheet compression molded ultrahigh molecular weight polyethylene (UHMWPE) conforming to ASTM F-648. The modifications to the manufacturing process of this polyethylene will be introduced to create a higher cross-linked polyethylene.

The safety and effectiveness of this cross-linked polyethylene in acetabular applications, as well as the proposed wear claims, are supported by the substantial equivalence information, materials data and testing results provided within this Supplement #3 to K990330, the original 510(k) submission (K990330), and Supplements #1 and #2 to K990330.

Cross-Linked Acetabular Implex Polyethylene Components are substantially equivalent to the above identified predicate devices and for the associated component sizes.

Statement of Technological Comparison:

Conclusion:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2000

Dr. Robert A. Poggie Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

Re: K990330

Trade Name: Cross-linked Polyethylene Acetabular Components Regulatory Class: II Product Code: JDI and LPH Dated: December 2, 1999 Received: December 3, 1999

Dear Dr. Poggie:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Dr. Robert A. Poggie

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K990330
Device Name:	Implex Cross-Linked Polyethylene AcetabularComponents
Indications For Use:	The Implex Cross-Linked Polyethylene AcetabularComponents are intended to be used with the belowlisted, legally marketed Implex Acetabular ComponentReplacement Systems to resurface the acetabularsocket in cemented or cementless total hiparthroplasty.

Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads:

• 1. The Implex HEP (Hedrocel) Acetabular Cup, cemented & cernentless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
• 2. The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
• 3. The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10 ° and 20° face angle options.
• 4. The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.

	Concurrence of CDRH; Office of Device Evaluation (ODE)
--	--------------------------------------------------------

Prescription Use(Per 21 CFR 801.109)	N/A
	OR...
	No
	Over-The-Counter Use
	No
(Division Sign-Off)Division of General Restorative Devices
510(k) Number	K990330
	(Optional Format 1-2-96)

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

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.