(104 days)
No
The document describes a mechanical implant (acetabular cup system) and its components, materials, and performance testing. There is no mention of software, algorithms, image processing, or any other technology that would typically incorporate AI/ML.
Yes
The device is an implant for total hip arthroplasty, intended to reduce pain and improve hip function, clearly indicating a therapeutic purpose.
No
Explanation: This device is a total hip arthroplasty system (Prime Acetabular Cup System) used for surgical implantation to replace a hip joint, not to diagnose a condition. Its intended use is for reduction or relief of pain and/or improved hip function, and revision procedures.
No
The device description clearly outlines physical components made of titanium alloy and polyethylene, which are hardware. The performance studies also focus on bench 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 arthroplasty to treat conditions affecting the hip joint. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device components (acetabular shells, liners, bone screws) are all physical implants designed to be surgically placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.
Therefore, the Prime Acetabular Cup System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusio acetabuli, and painful hip dysplasia:
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, HWC
Device Description
The Prime Acetabular Cup System includes acetabular shells, acetabular liners, and optional cancellous bone screws. The design features are summarized below:
- · Acetabular Shells
- Manufactured from titanium alloy о
- BIOFOAM® coated o
- Available in Solid or Quad configurations o
- Outer Diameter sizes 42mm to 68mm in 2mm increments O
- Acetabular Liners ●
- Manufactured from A-CLASS® (highly crosslinked ultra-high molecular o weight polyethylene)
- Lipped Available in in Standard, or Face-changing Lateralized O configurations with 12 anti-rotational tabs
- Inner Diameter sizes 22mm to 44mm O
- Bone Screws ●
- Manufactured from titanium alloy o
- 6.5mm diameter O
- 0 Available in lengths 15mm to 80mm in 5mm increments
The subject Acetabular Liner has undergone design changes in regard to the locking detail; all other design aspects, intended use, fundamental scientific technology, and material remain identical to the predicate K170444 Acetabular Liner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
skeletally mature patients
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)
Nonclinical bench testing was performed on the subject device to establish the basis for substantial equivalence. The lock detail of the subject Prime Acetabular Cup System was evaluated by testing Pre- and Post- Fatigue Push-out, Lever-out and Torque-out of the Liner. Push-out and Torque-out testing was performed in accordance with ASTM F1820. Lever-out was performed in accordance with ASTM STP1301 and per testing found in literature.
Bacterial endotoxin testing was performed for the subject Acetabular Liners per ANSVAAMI ST72:2011; endotoxins were found to me less than the USP endotoxin limit of 20 EU/device.
The following tests were performed for the predicate PROCOTYL® PRIME Acetabular Cup System (K170444), and were determined to be applicable to the subject System through worst case assessment:
- Deformation and frictional torque per ISO 7206-12 ●
- Wear and wear particle analysis per ASTM F1714-96, ISO 14242-1, ISO 14242o 2, and ASTM F1877-05
- o Long-term fatigue per FDA Draft Guidance Documents "Guidance Document for Testing Acetabular Cup Prostheses" and "Guidance Document for Testing Non-Articulating 'Mechanically-Locked' Modular Implant Components'', both issued May 1, 1995
- Range of motion per ISO 21535
- Screw properties per ASTM F543 ●
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.
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.
K002149, K052026, K082924, K002149, K061547, K070785, K082924, K934765, K953490, K010170, K090998
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
July 9, 2018
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. The overall design is clean and professional, reflecting the organization's role in public health and safety.
MicroPort Orthopedics Inc. Sarah Stroupe Sr. Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K180798
Trade/Device Name: Prime Acetabular Cup 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: LPH, LZO, HWC Dated: June 8, 2018 Received: June 11, 2018
Dear Sarah Stroupe:
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 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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K180798
Device Name Prime Acetabular Cup System
Indications for Use (Describe)
Indications for Use
-
non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
inflammatory degenerative joint disease such as rheumatoid arthritis;
-
correction of functional deformity; and,
-
revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a red diamond shape with a white outline. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red underneath. Below the logo is the text "MicroPort Orthopedics Inc." in black.
510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Substantial Equivalence for the use of the Prime Acetabular Cup System.
| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington TN, 38002
Phone: 866-872-0211
Fax: 855-446-2247 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | June 8, 2018 |
| Contact Person: | Sarah Evonne Stroupe
Sr. Regulatory Affairs Specialist |
| Proprietary Name: | Prime Acetabular Cup System |
| Common Name: | Acetabular Shell, Acetabular Liner, Bone Screw |
| Classification Name and
Reference: | 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-
constrained porous-coated uncemented prosthesis - Class
II
21 CFR 888.3353 - Hip joint metal/ceramic/polymer
semi-constrained cemented or nonporous uncemented
prosthesis - Class II
21 CFR 888.3040 - Smooth or threaded metallic bone
fixation fastener - Class II |
| Subject Product Code and Panel
Code: | Orthopedics/87/LPH, LZO, HWC |
| Predicate Device: | PROCOTYL® PRIME Acetabular Cup System
(K170444) |
| Reference Devices: | LINEAGE® Acetabular System (K002149 – Shell;
K052026 - Liner)
DYNASTY® Acetabular System (K082924 – Shell;
K002149, K061547, K070785, K082924 – Liner)
Zimmer Biomet Trilogy Acetabular Cup System
(K934765, K953490)
Stryker Trident Acetabular Cup System (K010170)
Depuy Pinnacle 100 Shell (K090998) |
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Image /page/4/Picture/0 description: The image shows the text 'K180798' in a simple, sans-serif font. The text is presented in a straightforward manner, with each character clearly legible. The black color of the text contrasts with the white background, enhancing its visibility.
Image /page/4/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in red underneath it. Below the logo is the text "MicroPort Orthopedics Inc." in black.
DEVICE INFORMATION
A. Intended Use
The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusio acetabuli, and painful hip dysplasia:
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
Similar to the explanation that was given in K111699 for MicroPort hip stems, these indications were stated as five (5) items (cleared with K971429, K002149 and K043099) and were eventually consolidated to four (4) items (as first cleared with hip stem K041114). The current indications are applied to all MicroPort polyethylene total acetabular systems and have been cleared in K052026, K061547, K070785, K072656, K082924, K122382, K130376, K140043, K170444, and K171181.
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Image /page/5/Picture/0 description: The image shows the text 'K180798' in a simple, sans-serif font. The text is presented in a clear and legible manner. The characters are uniformly sized and spaced, contributing to the overall readability of the image. The black text contrasts with the white background.
Image /page/5/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red underneath. Below the logo is the text "MicroPort Orthopedics Inc." in black.
B. Device Description
The Prime Acetabular Cup System includes acetabular shells, acetabular liners, and optional cancellous bone screws. The design features are summarized below:
- · Acetabular Shells
- Manufactured from titanium alloy о
- BIOFOAM® coated o
- Available in Solid or Quad configurations o
- Outer Diameter sizes 42mm to 68mm in 2mm increments O
- Acetabular Liners ●
- Manufactured from A-CLASS® (highly crosslinked ultra-high molecular o weight polyethylene)
- Lipped Available in in Standard, or Face-changing Lateralized O configurations with 12 anti-rotational tabs
- Inner Diameter sizes 22mm to 44mm O
- Bone Screws ●
- Manufactured from titanium alloy o
- 6.5mm diameter O
- 0 Available in lengths 15mm to 80mm in 5mm increments
The subject Acetabular Liner has undergone design changes in regard to the locking detail; all other design aspects, intended use, fundamental scientific technology, and material remain identical to the predicate K170444 Acetabular Liner.
C. Substantial Equivalence Information
The indications for use of the Prime Acetabular Cup System are identical to those for the predicate devices. The identical highly crosslinked UHMWPE material was characterized for the reference Acetabular Liner in K052026, and is equivalent to the material used in the predicate Acetabular Liner in K170444. The design features are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the subject devices has not changed relative to the predicate devices.
The design features of the subject Acetabular Shells, Cancellous Bone Screws, and all Instrumentation associated with the subject System have undergone no changes to intended use, fundamental scientific technology, or design since their clearance as part of K170444.
The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/6/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with a white circle inside, and a red diamond inside the white circle. To the right of the logo is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below the logo is the text "MicroPort Orthopedics Inc." in black.
D. Nonclinical Testing
Nonclinical bench testing was performed on the subject device to establish the basis for substantial equivalence. The lock detail of the subject Prime Acetabular Cup System was evaluated by testing Pre- and Post- Fatigue Push-out, Lever-out and Torque-out of the Liner. Push-out and Torque-out testing was performed in accordance with ASTM F1820. Lever-out was performed in accordance with ASTM STP1301 and per testing found in literature.
Bacterial endotoxin testing was performed for the subject Acetabular Liners per ANSVAAMI ST72:2011; endotoxins were found to me less than the USP endotoxin limit of 20 EU/device.
The following tests were performed for the predicate PROCOTYL® PRIME Acetabular Cup System (K170444), and were determined to be applicable to the subject System through worst case assessment:
- Deformation and frictional torque per ISO 7206-12 ●
- Wear and wear particle analysis per ASTM F1714-96, ISO 14242-1, ISO 14242o 2, and ASTM F1877-05
- o Long-term fatigue per FDA Draft Guidance Documents "Guidance Document for Testing Acetabular Cup Prostheses" and "Guidance Document for Testing Non-Articulating 'Mechanically-Locked' Modular Implant Components'', both issued May 1, 1995
- Range of motion per ISO 21535
- Screw properties per ASTM F543 ●
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Biocompatibility
The intended patient contact and materials used in the subject implant devices are identical to those of the predicate devices. No subject implants use colorants. Therefore, biocompatibility testing was not completed on the subject implant devices.
Instrumentation for the subject devices is the same as submitted in K170444.
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Image /page/7/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with a white circle and a red diamond inside. To the right of the square is the text "MicroPort" in blue and "Orthopedics" in red. Below the logo is the text "MicroPort Orthopedics Inc." in black.
G. Component and Accessory Compatibility
Tables 1 and 2 show the compatibility of the subject device with previously cleared MicroPort Orthopedics products.
| 510(k) | Intended Combinations |
|---|---|
| Subject Liners Compatibility with Modular Femoral Heads (up to 44mm) | |
| K893685 | Ceramic-Polyethylene with ID 28-36mm** |
| K920593 | Ceramic-Polyethylene, OD 28mm |
| K925512 | Ceramic-Polyethylene, OD 28mm |
| K932222 | Metal-Polyethylene, OD 28mm XXL |
| K002149 | Metal-Polyethylene with ID 22-32mm |
| K021349* | Metal-Polyethylene with ID 38-56mm |
| K004043* | Metal-Polyethylene with ID 28-36mm |
| K051348* | Metal-Polyethylene with ID 38-56mm |
| K072656 | Ceramic-Polyethylene with ID 38-46mm with neck sleeves |
| K130376 | Ceramic-Polyethylene with ID 32-40mm |
| K140043 | Ceramic-Polyethylene with ID 28mm |
| Subject Shell Compatibility with Bone Screws | |
| K864626 | Cancellous Bone Screws |
| K170444 | Optional Cancellous Bone Screws |
| Subject Screws Compatibility with Acetabular Shells*** | |
| K002149 | LINEAGE® System Shells |
| K061547 | DYNASTY® PC Shells |
| K070785 | DYNASTY® PC Shells |
| K082924 | DYNASTY® BIOFOAM® Shells |
| K122382 | DYNASTY® BIOFOAM® Shells |
| K142119 | PROCOTYL® L/O Shells |
| K170444 | PROCOTYL® PRIME Shells |
| Subject Shell Compatibility with Liners*** | |
| K170444 | PROCOTYL® PRIME Acetabular Liners |
| Subject Liner Compatibility with Shells | |
| K170444 | PROCOTYL® PRIME Acetabular Shells |
Table 1: Prime Acetabular Cup System Compatibility
- Metal femoral heads in K021349, K004043 and K051348 were originally cleared for use with metalmetal bearings, and later cleared for compatibility with DYNASTY® A-CLASS® polyethylene liners in K070785.
**36mm Forte Ceramic heads were originally cleared for use in PMA P030027, and later cleared for compatibility with PROCOTYL® L/O Acetabular System in K142119.
***The subject Shells and Screws were originally cleared for use in K170444. No changes have been made to these components' indications for use, fundamental scientific technology, or design.
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Image /page/8/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Underneath the entire logo is the text "MicroPort Orthopedics Inc." in black.
| 510(k) | Device Name |
|---|---|
| K003016 | PRO-FEMUR R |
| K012091 | PRO-FEMUR |
| K021346 | STEM HIP REPLACEMENT SYSTEM |
| K041114 | PROFEMUR TAPERED HIP STEM |
| K041586 | PROFEMUR S HIP STEM |
| K051995 | PROFEMUR RENAISSANCE HIP STEM |
| K052915 | PROFEMUR XTR HIP STEM |
| K053588 | PROFEMUR LX HIP STEM |
| K060358 | PROFEMUR TL HIP STEM |
| K080663 | PROFEMUR LX REVISION 5/8 COATED HIP STEM |
| K081090 | PROFEMUR LX 5/8 COATED HIP STEM |
| K091423 | |
| K100866 | PROFEMUR HIP SYSTEM MODULAR NECKS |
| K110399 | GLADIATOR PLASMA CLASSIC HIP STEM |
| K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM |
| K111699 | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM |
| K111910 | GLADIATOR HIP STEM |
| K112080 | PRESERVE HIP STEM |
| K112150 | PROFEMUR GLADIATOR HA HIP STEM |
| K121221 | PROFEMUR Z REVISION HIP STEM |
| K123434 | PROFEMUR Z CLASSIC STEM |
| K123688 | PROFEMUR TL CLASSIC STEM |
| K130984 | PROFEMUR RENAISSANCE CLASSIC STEM |
| K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS |
| K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS |
| K150133 | PROFEMUR PRESERVE SIZE 1-3 HIP STEMS |
| K150302 | PROFEMUR PRESERVE CLASSIC STEM |
Table 2: Compatible Femoral Components, Including 510(k) Information.
The Prime Acetabular Cup System instrumentation includes reamers, trial shells, trial liners, impactors and impactor handles, extraction instruments, and screw instruments. The Prime Acetabular Cup System may be used with alternative surgical approaches submitted in K122382; related instrumentation is included in the subject biocompatibility and surgical technique information.
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Image /page/9/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle with a red diamond shape in the center. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" underneath in red. Below the logo is the text "MicroPort Orthopedics Inc." in black.
H. Sterilization Residuals
Summary residuals results related to Ethylene Oxide sterilization were provided previously in K140043 and remain applicable to the subject device. Worst case was established based on product, density, size, and worst case Ethylene Oxide sterilization conditions.
Sterility of the subject Acetabular Liners was evaluated per AAMI TIR 28:2009 Annex A. The analysis determined that sterilization residuals are within the limits established by the worst case.
I. Conclusions
The indications for use and fundamental scientific technology of the Prime Acetabular Cup System are equivalent to the predicate device and similar to the reference devices. The design of the subject Acetabular Shells and Optional Cancellous Bone Screws remains unchanged since their clearance as part of K170444. The materials of the subject device are identical to the predicate device. The design features, materials information, predicate and subject testing, and analysis provided to support the substantial equivalence of the Prime Acetabular Cup System.