A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
Acute traumatic fracture of the femoral head or neck; -
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total .hip replacement.

The PBP Total Hip System hip stems and porous structured acetabular shells are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The PBP Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

Device Description

The PBP Total Hip System is an artificial hip replacement system. The system includes femoral stems, femoral heads, acetabular shells, acetabular liners, acetabular bone screws and dome hole covers (occluders) for the holes in the acetabular shells.

The PBP Femoral Stems are forged titanium alloy and feature a proximal roughened surface (plasma-sprayed CP Titanium), a polished tapered neck, a flat tapered geometry with reduced A/P width (wedge design), and a contoured distal tip and reduced lateral shoulder. The PBP Femoral Stems come in a range of sizes, and are offered in two offset neck options per size.

The PBP Femoral Heads are available in a polished cobalt chromium alloy or a high purity alumina oxide ceramic compound (Biolox® delta). The heads come in a range of diameters and extension options. The variety of head and stem sizes accommodates differences in patient anatomy.

The PBP PST™ (Porous Structured Technology) Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface or an HA porous structured surface. The shells feature a dome hole, are available with or without a cluster screw hole pattern for supplemental bone screw fixation, and come in a range of outer diameter sizes. The porous structured surface provides biologic fixation.

The PBP Acetabular Liners are manufactured from standard UHMWPE, or from highly crosslinked Vitamin E UHMWPE (XLVE™). The liners are mechanically assembled to the mating shells via engagement of the tightly toleranced liner taper and shell bore. The liners are available in a range of sizes and in neutral, high wall, and offset versions.

Optional components include a threaded acetabular dome hole occluder and acetabular bone screws, all manufactured from titanium alloy.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary for the PBP Total Hip System:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the PBP Total Hip System, acceptance criteria are typically defined by recognized standards (e.g., ISO, ASTM) for safety and performance, and the device's performance is demonstrated by meeting these standards. The acceptance criteria themselves are the limits or thresholds specified within these standards.

Test Category	Acceptance Criteria (as per referenced standards)	Reported Device Performance
Biocompatibility	Meets ISO 10993 series requirements for various biological effects (Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity, Sub-acute/Subchronic Systemic Toxicity, Genotoxicity, Muscle Implantation).	All Biocompatibility tests met the requirements of the respective ISO 10993 standards. (Specific pass/fail for each not detailed but implied by clearance).
Wear Testing (highly crosslinked Vitamin E Polyethylene)	In accordance with ISO 14242-1 (standard walking gait cycle) for poly liners; bidirectional pin-on-disc abrasive wear testing to demonstrate reduced wear compared to conventional poly; exhaustive extraction to show no new radiation degradation products vs. predicate.	• Wear tested per ISO 14242 (28mm, 36mm, 40mm liners, EO-sterilized, accelerated aged per ASTM F2003). • Bidirectional pin-on-disc: 35% wear reduction in clean serum (7.7 mg/Mc for standard vs 5 mg/Mc for Vitamin E); 58% wear reduction in abrasive environment (8.3 mg/Mc for standard vs 3.5 mg/Mc for Vitamin E). • Wear particle characterization was conducted. • Exhaustive extraction (with GCMS and LCMS analysis): Results demonstrated no new radiation degradation products released compared to predicate material.
Oxidation Analysis (highly crosslinked Vitamin E Polyethylene)	Per ASTM F2102-06, after accelerated aging per ASTM F2003, wear testing, and exhaustive extraction; lower oxidation indices than standard poly.	• Mean surface oxidation index: 0.017 (Vitamin E) vs. 0.097 (standard poly). • Maximum oxidation index: 0.029 (Vitamin E) vs. 0.248 (standard poly). • Bulk oxidation index: 0.009 (Vitamin E) vs. 0.036 (standard poly). (Demonstrates higher resistance to oxidation).
Consolidation (highly crosslinked Vitamin E Polyethylene)	Equivalent consolidation to a predicate material after accelerated aging per ASTM F2003 and wear testing, as evaluated by polarized light microscopy and SEM analysis.	Evaluation demonstrated equivalent consolidation to a predicate material.
Liner Assembly/Disassembly Testing	Meets force/torque requirements for push-out, lever-out torque, and axial torque for worst-case size liners.	Worst-case size conventional poly liner and highly crosslinked Vitamin E poly acetabular liner were tested for push-out, lever out torque, and axial torque. (Specific values not given, but implied to meet criteria).
Hip Stem Fatigue Testing	Per ISO 7206-4:2010 (Endurance Properties and Performance of Stemmed Femoral Components).	Worst-case (smallest) hip stem was tested according to ISO 7206-4:2010. (Implied to meet endurance requirements).
Stem Neck Fatigue Testing	Per ISO 7206-6:1992 and ASTM F2068-03 (Standard Specification for Femoral Prostheses - Metallic Implants).	Worst-case size was tested according to ISO 7206-6:1992 and ASTM F2068-03. (Implied to meet fatigue requirements).
Femoral Head Pull-off Testing	Meets required pull-off force.	Conducted on metal and ceramic femoral heads. (Implied to meet criteria).
Femoral Head Burst Strength Testing	Per ISO 7206-10.	Conducted on Biolox delta Femoral Heads according to ISO 7206-10. (Implied to meet burst strength requirements).
Range of Motion (ROM) Analysis	Meets physiological ROM requirements per ISO 21535 (flexion/extension, abduction/adduction, internal/external rotation).	Analysis was conducted to determine typical and worst-case ranges of motion for various liner/head/stem combinations. ROM was reported for flexion/extension, abduction/adduction, and internal/external rotation per ISO 21535. (Implied to meet criteria).
Bone Screw Testing	Per ASTM F543-07 (Metallic Medical Bone Screws) for torsion (torque to failure) and screw pull-out (pull-out to failure).	Conducted for torsion (torque to failure) and screw pull-out (pull-out to failure) according to ASTM F543-07. (Implied to meet criteria).
Porous Structured Surface Characterization	Meets relevant aspects of "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement."	Characterization completed for Acetabular Shell – PST Surface, Acetabular Shell – HA PST Surface, and Hip Stem - Plasma-Spray Titanium Coating.
Ceramic Head Characterization	Meets relevant aspects of "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball HIP Systems."	Characterization completed for the ceramic femoral heads.
Biologic Response (Porous Structured Surface)	Demonstrates favorable biological response (e.g., bone ingrowth, lack of adverse reaction) in a transcortical canine model.	Evaluated in a transcortical canine model at intervals up to 12 weeks, using histological and mechanical evaluations (implied to demonstrate acceptable biological response).

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

Sample Size for Test Set:
- Wear Testing: 28mm, 36mm, and 40mm inner diameter highly crosslinked Vitamin E poly liners were tested (number of units per size not specified).
- Liner Assembly/Disassembly Testing: "worst case size Pipeline Hip System highly crosslinked Vitamin E poly acetabular liner and worst case size conventional poly liner" (number of units not specified).
- Hip Stem Fatigue Testing: "worst case (smallest) hip stem" (number of units not specified, but typically multiple samples are tested to establish a statistical confidence).
- Stem Neck Fatigue Testing: "worst-case size" (number of units not specified).
- Porous Structured Surface Biologic Response: "a transcortical canine model" (number of canines not specified, but generally a small, controlled animal study).
- Other tests (biocompatibility, oxidation, consolidation, pull-off, burst strength, bone screw, characterization) would also have specific sample sizes, but these are not explicitly detailed in the summary beyond "testing was conducted" or "analysis was conducted." The phrase "worst case" implies a focus on challenging conditions relevant to product safety.
Data Provenance: The document does not specify the country of origin for the data, but it is a submission to the US FDA, implying that the data was generated or compiled for US regulatory review. The studies are pre-clinical/pre-market performance evaluations conducted in a laboratory or animal setting, not human clinical trials. Thus, the data provenance is from controlled laboratory/animal studies. The studies are prospective in nature, as they were designed and executed to gather specific performance data for the device.

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

This type of information (experts for ground truth) is not applicable to this 510(k) submission. The PBP Total Hip System is a mechanical orthopedic implant, and its performance is evaluated against engineering and biological standards using objective measurements in laboratory and animal models. "Ground truth" established by human experts (like radiologists for image analysis) is typically relevant for diagnostic devices or AI algorithms that interpret complex human data.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts, which is not the methodology for evaluating the mechanical and biological performance of an orthopedic implant.

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

This is not applicable to this device. An MRMC study is designed for evaluating diagnostic devices or AI algorithms that assist human interpretation of medical images or data. The PBP Total Hip System is a physical implant, not a diagnostic or AI-assisted device.

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

This is not applicable to this device. This concept relates to the performance of an AI algorithm independently, which is not relevant for a hip implant.

7. The Type of Ground Truth Used

For this device, the "ground truth" is defined by:

Engineering Standards: Specific values, thresholds, and methodologies outlined in international (e.g., ISO) and national (e.g., ASTM) standards for material properties, mechanical strength, fatigue life, wear rates, and range of motion.
Predicate Device Comparison: The performance of the predicate devices implicitly sets a "ground truth" for acceptable performance for substantial equivalence. For instance, the oxidation resistance and wear rates are compared directly to predicate/standard materials.
Biological Response: Histological and mechanical evaluations in the canine model serve as the "ground truth" for assessing the biological fixation and response of the porous surface.

8. The Sample Size for the Training Set

This is not applicable to this device. "Training set" refers to data used to train machine learning models. This 510(k) describes performance testing for a physical orthopedic implant, not an AI or software device.

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

This is not applicable to this device, as there is no "training set."

Summary

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510(k) Summary: K122158

The following 510k Summary is provided in accordance with the requirements of 21 CFR 807.92.

PBP Total Hip System

prosthesis

prosthesis)

uncemented Orthopedic

Artificial Total Hip Replacement

constrained cemented prosthesis)

888.3358 - Hip joint metal/polymer/metal semi-

888.3350 - Hip joint metal/polymer semi-

LPH - prosthesis, hip, semi-constrained,

OQH - hip, semi-constrained, cemented, metal/polymer + additive, cemented MEH (hip, semi-constrained, uncemented,

OQI - hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous

metal/polymer, porous uncemented JDI - prosthesis, hip, semi-constrained,

metal/polymer, cemented

constrained porous-coated uncemented prosthesis

888.3353 - Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented

OQG - hip prosthesis, semi-constrained, cemented; metal/polymer, + additive, porous, uncemented

metal/polymer, non-porous, calcium-phosphate) LZO (Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented

1. Device Name and Classification

Device Trade Name: Device:

Regulation Number and Description:

Device Class: Product Codes:

Advisory Panel:

2. Address and Registration

Submitter's Name: Address: Contact Person: Telephone Number: Fax Number:

Pipeline Biomedical Products, LLC 3 Wing Drive Suite 102 Cedar Knolls, NJ 07927 Robert C. Cohen (973) 267-8800 (973) 267-8810

Page 1 of 5

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112158

Date Summary Prepared: Establishment Registration Number: December 5, 2012 · Not yet registered

3. Purpose of Submission

The purpose of this submission is to obtain 510k clearance for the PBP Total Hip System, a new device system for Pipeline Biomedical Products, LLC.

4. Identification of Legally Marketed Device to which Submitter Claims Equivalence

The subject PBP Total Hip System by Pipeline Biomedical Products is substantially equivalent to the predicate devices as outlined in the following table.

Table 1: Predicate Devices
Device Name	Company	510(k) Number	Clearance Date
Pipeline Total Hip System	Pipeline Orthopedics	K112802	3/9/2012
Tritanium® Peri-Apatite Acetabular Shell System	Howmedica Osteonics	K101072 K971206	4/11/20112/11/1998
Biolox delta Ceramic Femoral Head	Zimmer	K071535	11/19/2007

Predicate Device

5. Device Description

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Optional components include a threaded acetabular dome hole occluder and acetabular bone screws, all manufactured from titanium alloy.

6. Intended Use

The PBP Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: '

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
Acute traumatic fracture of the femoral head or neck; -
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total .hip replacement.

The PBP Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

7. Comparison of Technological Characteristics

The PBP Total Hip System is manufactured from the same materials as the predicate device systems. In addition, the components are packaged, and sterilized using similar processes. The subject Total Hip System is substantially equivalent to the predicates based on comparisons of intended use, design features and technological characteristics.

8. Performance Testing

The following performance tests were provided to demonstrate substantial equivalence:

Biocompatibility testing for the highly crosslinked Vitamin E Polyethylene: .
- Cytotoxicity, 10993-5 o
- Maximization/Sensitization, 10993-10 o
- Intracutaneous, 10993-10 O
- Acute Systemic Toxicity, 10993-11 o
- Sub-acute/Subchronic Systemic Toxicity, 10993-11 O
- Genotoxicity, 10993-3 O
- Muscle Implantation, 10993-6. O
- Wear testing:

●

Testing was conducted on 28. mm, 36mm and 40mm inner diameter highly crosslinked Vitamin E poly liners, that had been EO-sterilized and accelerated aged in

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accordance with ASTM F2003, and subject to wear testing in accordance with ISO 14242, using a standard walking gait cycle as specified by ISO 14242-1.

Bidirectional pin-on-disc abrasive wear testing was also conducted to compare the o wear rates of the highly-crosslinked Vitamin E poly material to conventional (standard) gamma sterilized poly under clean and abrasive conditions. The wear reduction for the Vitamin E poly over conventional poly is 35% (7.7 vs 5 mg/Mc) in clean serum and 58% (8.3 vs 3.5 mg/Mc) in an abrasive environment.
Wear particle characterization was conducted.

KILLAS

The highly-crosslinked Vitamin E Polyethylene underwent exhaustive extraction testing using both polar and non-polar solvents, with GCMS and LCMS analysis to determine all volatile, semi-volatile, and non-volatile extracts. The results were compared to a predicate material to demonstrate that no new radiation degradation products are released by the material.
Highly-crosslinked Vitamin E Polyethylene liners underwent oxidation analysis per ASTM F2102-06 after accelerated aging per ASTM F2003, wear testing, and exhaustive extraction. The analysis was also conducted on gamma-sterilized GUR 1020 (standard poly) reference material for comparison. The highly crosslinked Vitamin E poly exhibited lower oxidation indices than the standard poly, demonstrating higher resistance to oxidation: mean surface oxidation index was 0.017 for Vitamin E and 0.097 for standard poly; maximum oxidation index was 0.029 for Vitamin E and 0.248 for standard poly; and bulk oxidation index was 0.009 for Vitamin E and 0.036 for standard poly.
Highly-crosslinked Vitamin E Polyethylene liners were evaluated by polarized light microscopy and SEM analysis of freeze fractured surfaces, after accelerated aging per ASTM F2003 and wear testing, to demonstrate that the subject material has equivalent consolidation to a predicate material.
Liner Assembly/Disassembly Testing: Testing of the worst case size Pipeline Hip System . highly crosslinked Vitamin E poly acetabular liner and worst case size conventional poly liner were tested for push-out, lever out torque, and axial torque.
Hip Stem Fatigue Testing was conducted for the worst case (smallest) hip stem . according to the method described in ISO 7206-4:2010, Implants for surgery-Partial and total hip joint prostheses, Determination of Endurance Properties and Performance of Stemmed Femoral Components.
Stem Neck Fatigue Testing of the worst-case size was conducted according to the . methods described in ISO 7206-6:1992 Implants for surgery-Partial and total hip joint prostheses-Part 6 and ASTM F2068-03 Standard Specification for Femoral Prostheses -Metallic Implants.
Pull off testing was conducted on the metal and ceramic femoral heads. .
Burst Strength testing was conducted on Biolox delta Femoral Heads according to ISO . 7206-10.
An analysis was conducted of the typical and worst case ranges of motion permitted by . the designs of various liner size/style, head size/style, and stem size/style combinations. for ROM was reported flexion/extension, abduction/adduction, and The internal/external rotation per ISO 21535.

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Bone screw testing was conducted in accordance with ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws, for torsion (torque to failure) and screw pull-out (pull-out to failure).
Characterization in accordance with relevant aspects of "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement," was completed for: 1) Acetabular Shell – PST Surface; 2) Acetabular Shell – HA PST Surface; 3) Hip Stem - Plasma-Spray Titanium Coating.
Characterization in accordance with relevant aspects of "Guidance Document for the � Preparation of Premarket Notifications for Ceramic Ball HIP Systems" was completed for the ceramic femoral heads.
. The porous structured surface was evaluated in a transcortical canine model to assess the biological response, using histological and mechanical evaluations, at intervals up to 12 weeks.

9. Conclusions

The subject PBP Total Hip System shares the same indications for use as the predicate hip system, and a comparison of technological characteristics supported by performance testing demonstrates the Substantial Equivalence of the PBP Total Hip System to the predicate hip systems.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human figures connected at the shoulders, forming a shape that resembles a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.

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

December 11, 2012

Pipeline Biomedical Products, Llc % Mr. Terry Powell Senior Project Manager 901 King Street, Suite 200 Alexandria. Virginia 22314

Re: K122158

Trade/Device Name: PBP Total Hip 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: OQI, LZO, MEH, OQH, OQG, JDI, LPH Dated: November 14, 2012 Received: November 19, 2012

Dear Terry Powell:

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

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Page 2 - Terry Powell

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 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

ErinFLDKeith

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K122158

Device Name: PBP Total Hip System

Indications for Use:

The PBP Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
Acute traumatic fracture of the femoral head or neck;
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty; surface replacement arthroplasty or total hip replacement.

The PBP Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krishna Asundi
Division of Orthopedic Devices

2012.12.10 16:53:59 -05'00'

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.