(144 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the hip replacement components, with no mention of AI or ML.
Yes
The device is an artificial hip replacement system, which is used to treat conditions causing severely painful and/or disabled joints, indicating a direct therapeutic purpose.
No
The PBP Total Hip System is described as an "artificial hip replacement system" intended for surgical replacement of a hip joint due to various conditions. It consists of prosthetic components like stems, heads, and shells, which are used for treatment and not for diagnosing a condition.
No
The device description clearly outlines physical components such as femoral stems, femoral heads, acetabular shells, liners, screws, and dome hole covers, all made of various materials like titanium alloy, cobalt chromium alloy, and UHMWPE. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The PBP Total Hip System is an artificial hip replacement system. Its intended use is to replace a damaged hip joint in skeletally mature individuals due to various conditions. It is an implantable medical device used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, laboratory testing, or diagnostic purposes.
Therefore, the PBP Total Hip System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OQI, LZO, MEH, OQH, OQG, JDI, LPH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
The following performance tests were provided to demonstrate substantial equivalence:
- Biocompatibility testing for the highly crosslinked Vitamin E Polyethylene:
- Cytotoxicity, 10993-5
- Maximization/Sensitization, 10993-10
- Intracutaneous, 10993-10
- Acute Systemic Toxicity, 10993-11
- Sub-acute/Subchronic Systemic Toxicity, 10993-11
- Genotoxicity, 10993-3
- Muscle Implantation, 10993-6.
- 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 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 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.
- 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K112802, K101072, K971206, K071535
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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: 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
ll
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
1
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 | 4/11/2011 | ||
2/11/1998 | |||
Biolox delta Ceramic Femoral Head | Zimmer | K071535 | 11/19/2007 |
Predicate Device
5. 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.
2
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.
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 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.
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
3
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.
4
- 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.
5
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
6
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
7
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 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.
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'