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 Pipeline Total Hip System is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

Device Description

The Pipeline Total Hip System is an artificial hip replacement system comprised of femoral stems and mating metal heads; acetabular shells and mating acetabular liners; optional acetabular bone screws; and optional acetabular dome hole occluders.
The Pipeline Femoral Stems are forged titanium alloy, feature a proximal roughened surface (plasma-sprayed CP Titanium), come in a range of sizes, and are offered in two offset neck options per size. The Pipeline Femoral Heads are polished cobalt chromium alloy and come in a range of diameters and extension options.
The Pipeline Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface (titanium alloy). 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 Pipeline Acetabular Liners are manufactured from ultrahigh molecular weight polyethylene (standard UHMWPE or highly crosslinked Vitamin E UHMWPE). The liners are mechanically assembled to the mating shells via engagement of the liner taper with the shell bore. Locking is achieved through engagement of interrupted poly rib at the taper to sphere transition of the liner with a mating groove on the shell. Poly tabs of the liner mate with scallops on the face of the shell to prohibit rotation of the liner. The liners are available in a range of sizes, and are available in neutral, high wall, +4mm offset, +4mm offset/10° elevated, and +4mm offset/high wall options.
Optional components include a threaded acetabular dome hole occluder and acetabular bone screws, all manufactured from titanium alloy.

AI/ML Overview

This 510(k) summary describes a medical device, the Pipeline Total Hip System, rather than an AI/ML product. Therefore, the traditional acceptance criteria and study design elements typically associated with AI/ML device evaluations (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable here.

The document primarily focuses on demonstrating the substantial equivalence of the Pipeline Total Hip System to legally marketed predicate hip systems. This is a regulatory pathway for medical devices that relies on showing that the new device is as safe and effective as devices already on the market.

Instead of AI/ML performance metrics, the acceptance criteria and supporting studies for this device relate to its physical properties, biocompatibility, and mechanical performance.

Below is a reinterpretation of your requested categories to fit the context of this medical device submission:

Acceptance Criteria and Device Performance (Adapted for Medical Device)

Acceptance Criteria Category	Description / Performance Demonstrated
Biocompatibility	- Highly crosslinked Vitamin E Polyethylene demonstrated biocompatibility through tests including Cytotoxicity, Maximization/Sensitization, Intracutaneous, Acute Systemic Toxicity, Sub-acute/Subchronic Systemic Toxicity, Genotoxicity, and Muscle Implantation, all in accordance with ISO 10993 series standards.- The Vitamin E raw material blend in the polyethylene is the same as the predicate highly crosslinked Vitamin E polyethylene.- Exhaustive extraction testing (GCMS and LCMS) showed no new radiation degradation products compared to a predicate material.
Wear Resistance	- Wear testing conducted on 36mm inner diameter highly crosslinked Vitamin E poly liners (EO-sterilized, accelerated aged per ASTM F2003, tested per ISO 14242 using standard walking gait cycle).- Bidirectional pin-on-disc abrasive wear testing compared wear rates of highly-crosslinked Vitamin E poly to conventional gamma-sterilized poly under abrasive conditions.- Wear particle characterization was conducted.- Oxidation analysis (ASTM F2102-06 after ASTM F2003 accelerated aging and wear testing) showed favorable results compared to gamma-sterilized GUR 1020.
Mechanical Integrity / Strength	- Liner Assembly/Disassembly Testing: Worst-case size highly crosslinked Vitamin E poly and conventional poly acetabular liners tested for push-out, lever-out torque, and axial torque.- Hip Stem Fatigue Testing: Worst-case (smallest) hip stem tested according to ISO 7206-4:2010.- Stem Neck Fatigue Testing: Worst-case size stem tested according to ISO 7206-6:1992 and ASTM F2068-03.- Head/Taper Strength: Average pull-off force demonstrated for worst-case sizes.- Bone Screw Testing: Worst-case diameter bone screws tested for torsion (torque to failure) and screw pull-out (pull-out to failure) per ASTM F543-07.
Range of Motion (ROM)	- Analysis conducted on typical and worst-case ranges of motion permitted by various liner size/style, head size/style, and stem size/style combinations. ROM reported for flexion/extension, abduction/adduction, and internal/external rotation per ISO 21535.
Coating Characterization & Biological Fixation (Porous Surfaces)	- Characterization of Hip Stem (Plasma-Spray Titanium Coating) and Acetabular Shell (Porous Structured Surface) according to "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement."- Porous structured surface evaluated in a transcortical canine model to assess biological response (histological and mechanical evaluations) up to 12 weeks. This demonstrates suitability for biological fixation in cementless applications.
Substantial Equivalence to Predicates	- The materials (metals, standard UHMWPE, highly crosslinked Vitamin E UHMWPE) comply with applicable implantable material standards and are equivalent to those used in predicate devices. - Design features are comparable to predicate hip systems. - The device is capable of withstanding anticipated physiological conditions. - The Pipeline Hip System shares the same indications for use as predicate hip systems. Overall, the device meets the criteria for substantial equivalence, implying it is as safe and effective as the predicate devices.

Non-Applicable/Re-interpreted AI/ML Specific Questions:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Interpretation: For this physical device, "test sets" refer to the samples and methods used in the various engineering, materials, and biological tests.
- Details:
  - Wear testing: 36mm inner diameter highly crosslinked Vitamin E poly liners (number not specified).
  - Liner Assembly/Disassembly: "worst case size" liners (number not specified).
  - Hip Stem Fatigue: "worst case (smallest)" hip stem (number not specified).
  - Stem Neck Fatigue: "worst-case size" (number not specified).
  - Head/Taper Strength: "worst-case sizes" (number not specified).
  - Bone Screw Testing: "worst-case diameter" for torsion and pull-out (number not specified).
  - Porous Surface Biological Response: Transcortical canine model (number of animals not specified, but this would be a prospective animal study).
- Provenance: All tests were conducted in a laboratory setting (in-vitro, ex-vivo, or animal model) to established international standards (ISO, ASTM). This is not human data and therefore "country of origin" or "retrospective/prospective" in the clinical sense are not directly applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Interpretation: This is not applicable. For a physical medical device, "ground truth" is established by direct measurement, observation, and adherence to validated testing standards (ISO, ASTM). The "experts" are the engineers, materials scientists, and biologists performing and interpreting these standardized tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Interpretation: Not applicable. Testing results are based on objective measurements against pass/fail criteria defined by relevant standards, not subjective human assessment needing adjudication.
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:
- Interpretation: Not applicable as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Interpretation: Not applicable as this is not an AI/ML device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Interpretation: For this device, the "ground truth" is defined by adherence to established engineering and material science standards (e.g., ISO 10993 for biocompatibility, ISO 14242 for wear, ISO 7206 for fatigue, ASTM F543 for screws), and pre-clinical biological observations (canine model for osseointegration).
The sample size for the training set:
- Interpretation: Not applicable as this is not an AI/ML device that requires a "training set." The design and manufacturing processes are likely informed by years of historical engineering data and predicate device performance, but not in the context of an AI training set.
How the ground truth for the training set was established:
- Interpretation: Not applicable as this is not an AI/ML device.

Summary

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510(k) Summary – K112802

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

Device Name and Classification

Device Trade Name:	Pipeline Total Hip System
Device:	Artificial Total Hip Replacement
Regulation Number and Description:	888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Device Class:	II
Product Codes:	LPH - prosthesis, hip, semi-constrained,metal/polymer, porous uncementedJDI - prosthesis, hip, semi-constrained,metal/polymer, cementedOQG - hip prosthesis, semi-constrained, cemented,metal/polymer, + additive, porous, uncementedOQH - hip, semi-constrained, cemented,metal/polymer + additive, cemented
Advisory Panel:	Orthopedic

Address and Registration

Submitter's Name:	Pipeline Orthopedics
Address:	3 Wing Drive Suite 102 Cedar Knolls, NJ 07927
Contact Person:	Robert C. Cohen
Telephone Number:	(973) 267-8800
Fax Number:	(973) 267-8810
Date Summary Prepared:	March 2, 2012
Establishment Registration	Not yet registered
Number

Identification of Legally Marketed Device to which Submitter Claims Equivalence

The subject device is substantially equivalent to the following hip systems or components:

System Components	Predicates
Acetabular Shells - PorousStructured	Biomet Regenerex Ringloc Plus - K070369
Acetabular Shells – Beaded Surface	Consensus Acetabular Shells – K060635

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K112802

Acetabular Liners – highlycrosslinked Vitamin E polyethylene	StelKast Exp Acetabular Liners - K094035
Acetabular Liners – standardpolyethylene	Stryker Trident Acetabular Shell System - K010170
Bone Screws and Dome HoleOccluder	Biomet: Regenerex Ringloc Plus Acetabular Shell System- K070369
Femoral Stems and CoCr Heads	Exactech AcuMatch P-Series Hip Stems – plasmasprayed – K102487, K042842, K041906 Or Smith &Nephew Anthology Plasma Sprayed Hip Stems -K052792

Device Description

The Pipeline Femoral Stems are forged titanium alloy, feature a proximal roughened surface (plasma-sprayed CP Titanium), come in a range of sizes, and are offered in two offset neck options per size. The Pipeline Femoral Heads are polished cobalt chromium alloy and come in a range of diameters and extension options.

The Pipeline Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface (titanium alloy). 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 Pipeline Acetabular Liners are manufactured from ultrahigh molecular weight polyethylene (standard UHMWPE or highly crosslinked Vitamin E UHMWPE). The liners are mechanically assembled to the mating shells via engagement of the liner taper with the shell bore. Locking is achieved through engagement of interrupted poly rib at the taper to sphere transition of the liner with a mating groove on the shell. Poly tabs of the liner mate with scallops on the face of the shell to prohibit rotation of the liner. The liners are available in a range of sizes, and are available in neutral, high wall, +4mm offset, +4mm offset/10° elevated, and +4mm offset/high wall options.

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

Intended Use

Pipeline 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; -

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Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
The Pipeline Total Hip System is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

Comparison of Technological Characteristics

The metals and standard UHMWPE material from which the components are manufactured are the same materials used in the predicate hip systems and comply with applicable implantable materials standards. The highly crosslinked Vitamin E UHMWPE material complies with applicable implantable materials standards, and the Vitamin E raw material blend in the polyethylene is the same as the predicate highly crosslinked Vitamin E polyethylene. Testing in accordance with the relevant sections of ISO 10993 demonstrates the highly crosslinked Vitamin E polyethylene material's biocompatibility. Further, wear testing demonstrates the suitability of the highly crosslinked Vitamin E UHMWPE for use as an acetabular bearing material in this hip system.

A comparison of design features of the Pipeline Total Hip System to the predicate hip systems, characterization of all porous surfaces in accordance with applicable FDA guidance, and performance testing confirm that the Pipeline Total Hip System is capable of withstanding the anticipated physiological conditions associated with the indications for use and is substantially equivalent to the predicate devices.

Performance Testing

트

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
- O Intracutaneous, 10993-10
- O Acute Systemic Toxicity, 10993-11
- Sub-acute/Subchronic Systemic Toxicity, 10993-11 O
- Genotoxicity, 10993-3 o
- Muscle Implantation, 10993-6. O
Wear testing: Testing was conducted on 36mm inner diameter highly crosslinked 피 Vitamin E poly liners, that had been EO-sterilized and accelerated aged in 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 wear rates of the highlycrosslinked Vitamin E poly material to conventional gamma sterilized poly under abrasive conditions.
트 Wear particle characterization was conducted.
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

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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 reference material for comparison.
. 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.
트 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.
Head/Taper Strength: The average pull off force was demonstrated for the worst-case sizes.
트 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. The ROM was reported for flexion/extension, abduction/adduction, and internal/external rotation per ISO 21535.
트 Bone screw testing was conducted in accordance with ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws, for the worst-case diameter 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) Hip Stem - Plasma-Spray Titanium Coating; and 2) Acetabular Shell - Porous Structured Surface.
The porous structured surface was evaluated in a transcortical canine model to assess 트 the biological response, using histological and mechanical evaluations, at intervals up to 12 weeks.

Conclusions

The Pipeline Hip System shares the same indications for use as the predicate hip systems, and a comparison of materials and design features, supported by mechanical testing, and biocompatibility testing, demonstrates the Substantial Equivalence of the Pipeline Total Hip System to one or more of the predicate hip systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

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

Pipeline Orthopedics % Ms. Terry Powell M-Squared Regulatory Consultant 901 King Street, Suite 200 Alexandria, Virginia 22314

MAR - 9 2012

Re: K112802

Trade/Device Name: Pipeline 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: OQG, OQH, LPH, JDI Dated: January 30, 2012 Received: February 1, 2012

Dear Ms. 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 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. Terry Powell

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 vours,

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 Statement

510(k) Number (if known): K112802

Device Name: Pipeline Total Hip System

Indications for Use:

Pipeline 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 Pipeline Total Hip System is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

Prescription Use _ × -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)

Qoue

tvision of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112802

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.