(139 days)
No
The document describes a mechanical hip replacement system and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a total hip replacement system, which clearly falls under the definition of a therapeutic medical device as it is intended to treat a severely painful and/or disabled joint.
No
Explanation: This device is an artificial hip replacement system, which is a therapeutic device intended for implantation, not for diagnosis. While it mentions the ability for surgeons to perform radiostereometric analysis (RSA) to measure implant migration, this is an assessment of the implanted device's performance post-implantation rather than a diagnostic function to identify a disease or condition.
No
The device description clearly outlines physical components like femoral stems, heads, shells, liners, screws, and dome hole covers, which are hardware. The submission also includes performance studies related to the fatigue testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip replacement. This is a device used in vivo (within the body) to replace a damaged joint.
- Device Description: The description details the components of an artificial hip replacement system, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / 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 Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.
Product codes
LPH, JDI
Device Description
The predicate Pipeline Total Hip System (K112802) and PBP Total Hip System (K122802) are artificial hip replacement systems that include femoral stems (titanium alloy and CP titanium), femoral heads (cobalt chromium or alumina ceramic), acetabular shells (titanium alloy, porous structured technology (PST™)), acetabular liners (ultrahigh molecular weight polyethylene, standard and highly crosslinked Vitamin E), acetabular bone screws (titanium alloy) and dome hole covers (titanium alloy) for the holes in the acetabular shells. This subject 510k adds the following components to the existing hip systems:
- A smaller, size 1 femoral stem; .
- The option of hip stems (all sizes) with 3 tantalum beads, to allow the surgeon to . perform radiostereometric analysis(RSA) to measure implant migration; and
- . The option of acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiostereometric analysis (RSA)
Anatomical Site
Hip joint
Indicated Patient Age Range
skeletally mature individuals
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)
Hip Stem Fatique 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, and Engineering Analysis was conducted to determine satisfactory distal boundary for the plasma spray coating.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112802, K122802, K061066, K022799
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
JUL 0 1 2013
The following 510k Summary is provided in accordance with the requirements of 21 CFR 807.92.
1.1. Device Name and Classification
Device Trade Name: Device Common Name:
Requlation Number and Description:
Device Class: Product Codes:
Pipeline Total Hip System Artificial Total Hip Replacement System Components 888.3358 - Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis = LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented JD! - prosthesis, hip, semi-constrained,
metal/polymer, cemented Orthopedic
Advisory Panel:
1.2. Address and Registration
Submitter's Name: Address:
Contact Person: Telephone Number: Fax Number: Date Summary Prepared:
Establishment Registration Number: 3009701876
Pipeline Biomedical Products, LLC 3 Wing Drive Suite 102 Cedar Knolls, NJ 07927 Robert C. Cohen (973) 267-8800 (973) 267-8810 February 11, 2013
Identification of Legally Marketed Device to which Submitter 1.3. Claims Equivalence
The subject Pipeline Total Hip System Line Extension is substantially equivalent to the predicate devices shown in the following table.
| Device Name | Company | 510(k)
Number | Clearance
Date |
|---------------------------|--------------------------------------------------------------|------------------|-------------------|
| Pipeline Total Hip System | Pipeline Orthopedics | K112802 | 3/9/2012 |
| PBP Total Hip System | Pipeline Biomedical Products | K122802 | 12/11/2012 |
| Synergy Hip System | Smith & Nephew Orthopedics | K061066 | 7/14/2006 |
| Trident Screw Hole Plugs | Stryker Orthopaedics (formerly
Howmedica Osteonics Corp.) | K022799 | 11/21/2002 |
1
1.4. Device Description
The predicate Pipeline Total Hip System (K112802) and PBP Total Hip System (K122802) are artificial hip replacement systems that include femoral stems (titanium alloy and CP titanium), femoral heads (cobalt chromium or alumina ceramic), acetabular shells (titanium alloy, porous structured technology (PST™)), acetabular liners (ultrahigh molecular weight polyethylene, standard and highly crosslinked Vitamin E), acetabular bone screws (titanium alloy) and dome hole covers (titanium alloy) for the holes in the acetabular shells. This subject 510k adds the following components to the existina hip systems:
- A smaller, size 1 femoral stem; .
- The option of hip stems (all sizes) with 3 tantalum beads, to allow the surgeon to . perform radiostereometric analysis(RSA) to measure implant migration; and
- . The option of acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells.
1.5. 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;
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.
Comparison of Technological Characteristics 1.6.
The Pipeline Total Hip System described in this 510k has the same indications for use as the predicate Pipeline Total Hip System. The additional Pipeline Total Hip System components described in this 510k have similar designs to one or more of the identified predicate devices, and are manufactured from the same materials as one or more of the predicate device systems, and/or from materials that comply with recognized implantable materials standards. The components are packaged and sterilized using the
2
same processes as one or more of the predicate devices. The subject Pipeline Total Hip System components are therefore substantially equivalent to the predicates based on comparisons of intended use, design features and technological characteristics, materials, and sterilization/packaging methods.
1.7. Performance Testing
The following performance tests and engineering analyses were provided to demonstrate substantial equivalence:
- Hip Stem Fatique 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, and Engineering Analysis was conducted to determine satisfactory distal boundary for the plasma spray coating.
- 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.
1.8. Conclusions
The subject Pipeline Total Hip System components share indications for use as the predicate Pipeline hip system, and a comparison of technological characteristics supported by performance testing demonstrates the Substantial Equivalence of the subject Pipeline Total Hip System components to one or more of the identified predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2013
Pipeline Orthopedics % M Squared Associates, Incorporated Ms. Terry Powell Senior Project Manager 901 King Street, Suite 102 Alexandria, Virginia 22314
Re: K130353
Trade/Device Name: Pipeline Total Hip System - Line Extension 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 Dated: May 30, 2013 Received: June 3, 2013
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 fiability 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
4
Page 2 - Ms. 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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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.
Erin ith
For
Mark Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K130353
Device Name: Pipeline Total Hip System - Line Extension
Indications for Use:
t
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 dvsplasia:
- 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 Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
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)
Elizabeth L. Frank -S
Division of Orthopedic Devices
Page 1 of 1
K130353, Al Response, Exhibit 1