(132 days)
K111699, K971429, K002149, K043099, K041114, K052026, K061547, K070785, K072656, K082924, K122382, K130376, K140043, K893685, K920593, K925512, K932222, K021349, K004043, K051348, K142119, P030027, K061547, K070785, K122382, K003016, K012091, K021346, K041114, K041586, K051995, K052915, K053588, K060358, K080663, K081090, K091423, K100866, K110399, K111698, K111910, K112080, K112150, K121221, K123434, K123688, K130984, K140676, K141235, K150133, K150302
No
The document describes a mechanical implant (acetabular cup system) and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on mechanical properties and wear, not algorithmic performance.
Yes
The device is an acetabular cup system intended for use in total hip arthroplasty to reduce or relieve pain and improve hip function in patients with various degenerative joint diseases and deformities, which directly addresses therapeutic goals.
No
The device is an acetabular cup system intended for use in total hip arthroplasty to treat conditions like osteoarthritis and improve hip function; it is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium alloy and polyethylene, such as acetabular shells, liners, and bone screws. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the PROCOTYL® PRIME Acetabular Cup System is for use in total hip arthroplasty in skeletally mature patients with specific joint conditions. This is a surgical procedure performed in vivo (within the body) to replace a damaged hip joint.
- Device Description: The device is described as an acetabular cup system, including shells, liners, and bone screws. These are physical implants designed to be surgically placed in the hip joint.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on bodily samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
The PROCOTYL® PRIME Acetabular Cup System is a surgical implant used for reconstructive purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The PROCOTYL® 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, HWC
Device Description
The PROCOTYL® PRIME Acetabular Cup System includes acetabular shells, acetabular liners, and optional cancellous bone screws. The design features are summarized below:
- . Acetabular Shells
- o Manufactured from titanium alloy
- 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 о weight polvethylene)
- Available in Standard. Lipped Face-changing or Lateralized о configurations
- Inner Diameter sizes 22mm to 44mm o
- Bone Screws ●
- Manufactured from titanium alloy o
- 6.5mm diameter о
- 0 Available in lengths 15mm to 80mm in 5mm increments
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 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 Testing:
The lock detail of the subject PROCOTYL® PRIME Acetabular Cup System was evaluated by testing Push-out, Lever-out and Torque-out of the Liner per ASTM 1820.
The subject System underwent deformation and frictional torque testing to evaluate the properties under pinch-loading conditions.
The subject System completed long term axial cyclic loading to evaluate fatigue resistance properties.
The subject System underwent wear testing to determine the wear rate and a wear particle analysis was performed on the wear debris.
Additionally, a range of motion study was completed for the PROCOTYL® PRIME Acetabular Cup System.
Finally, per ASTM F543, the properties of the cancellous bone screws were examined.
Clinical Testing:
Clinical data was not provided for the subject devices.
Biocompatibility:
The intended patient contact and materials used in the subject implant devices are identical to those of the predicate devices. Furthermore, that the materials and processing methods of the subject device are identical to predicates K002149, K082924, K052026, and K864626. No subject implants use colorants. Therefore, biocompatibility testing was not completed on the subject devices.
The Limulus Amebocyte Lysate (LAL) test was used to determine the subject devices meets the specified pyrogen limit specification of ≤ 20 EU/device.
For all associated instruments that were not previously cleared, Master File references were provided for raw material biocompatibility and manufacturing process effects on biocompatibility were evaluated.
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.
K002149, K052026, K864626, K082924, K934765, K953490, K090998
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.
K111699, K971429, K002149, K043099, K041114, K052026, K061547, K070785, K072656, K082924, K122382, K130376, K140043, K893685, K920593, K925512, K932222, K021349, K004043, K051348, K142119, P030027, K061547, K070785, K122382, K003016, K012091, K021346, K041114, K041586, K051995, K052915, K053588, K060358, K080663, K081090, K091423, K100866, K110399, K111698, K111910, K112080, K112150, K121221, K123434, K123688, K130984, K140676, K141235, K150133, K150302
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
Image /page/0/Picture/2 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MicroPort Orthopedics Inc. Kaitlin Grove Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
June 26, 2017
Re: K170444
Trade/Device Name: PROCOTYL® 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: Mav 24, 2017 Received: May 25, 2017
Dear Kaitlin Grove:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free 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" (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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
Expiration Date: January 31, 2017
See PRA Statement below.
Form Approved: OMB No. 0910-0120
Indications for Use
510(k) Number (if known)
Device Name
PROCOTYL® PRIME Acetabular Cup System
Indications for Use (Describe)
The PROCOTYL® 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, 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/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 red diamond with a white star in the center. 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.
PROCOTYL® PRIME Acetabular Cup System Traditional 510(k) 510(k) Summary
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 PROCOTYL® 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 22, 2017 |
| Contact Person: | Kaitlin Grove
Regulatory Affairs Specialist II |
| Proprietary Name: | PROCOTYL® PRIME Acetabular Cup System |
| Common Name: | acetabular shell, acetabular liner and 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: | LINEAGE® Acetabular System (K002149 – Shell)
LINEAGE® Acetabular System (K052026 - Liner)
Cancellous Bone Screw (K864626) |
| | DYNASTY® Acetabular System (K082924 Shells;
K002149, K061547, K070785, K082924 Liners) |
| | Zimmer Biomet Trilogy Acetabular Cup System
(K934765, K953490) |
| | Depuy Pinnacle 100 Shell (K090998) |
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Image /page/4/Picture/1 description: The image shows the text "Pg.2/6". The text is in a simple, sans-serif font and is positioned in the center of the image. The text likely refers to a page number within a larger document.
Image /page/4/Picture/2 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a white circle inside, containing a red diamond shape. To the right of the icon is the text "MicroPort" in blue, with "Orthopedics" underneath in red. Below the logo is the text "MicroPort Orthopedics Inc." in black.
DEVICE INFORMATION
A. Intended Use
The PROCOTYL® 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, 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.
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.
B. Device Description
The PROCOTYL® PRIME Acetabular Cup System includes acetabular shells, acetabular liners, and optional cancellous bone screws. The design features are summarized below:
- . Acetabular Shells
- o Manufactured from titanium alloy
- 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 о weight polvethylene)
- Available in Standard. Lipped Face-changing or Lateralized о configurations
- Inner Diameter sizes 22mm to 44mm o
- Bone Screws ●
- Manufactured from titanium alloy o
- 6.5mm diameter о
- 0 Available in lengths 15mm to 80mm in 5mm increments
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Image /page/5/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 with a red diamond shape in the center. 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.
C. Substantial Equivalence Information
The indications for use of the PROCOTYL® PRIME Acetabular Cup System are identical to those for the predicate devices. The identical highly crosslinked UHMWPE material was characterized for the predicate liner in K052026. The design features and materials 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 safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provide within this Premarket Notification.
D. Nonclinical Testing
The lock detail of the subject PROCOTYL® PRIME Acetabular Cup System was evaluated by testing Push-out, Lever-out and Torque-out of the Liner per ASTM 1820.
The subject System underwent deformation and frictional torque testing to evaluate the properties under pinch-loading conditions.
The subject System completed long term axial cyclic loading to evaluate fatigue resistance properties.
The subject System underwent wear testing to determine the wear rate and a wear particle analysis was performed on the wear debris.
Additionally, a range of motion study was completed for the PROCOTYL® PRIME Acetabular Cup System.
Finally, per ASTM F543, the properties of the cancellous bone screws were examined.
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. Furthermore, that the materials and processing methods of the subject device are identical to predicates K002149, K082924, K052026, and K864626. No subject implants use colorants. Therefore, biocompatibility testing was not completed on the subject devices.
The Limulus Amebocyte Lysate (LAL) test was used to determine the subject devices meets the specified pyrogen limit specification of ≤ 20 EU/device.
For all associated instruments that were not previously cleared, Master File references were provided for raw material biocompatibility and manufacturing process effects on biocompatibility were evaluated.
6
Image /page/6/Picture/2 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 square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below the logo is the text "MicroPort Orthopedics Inc." in black.
PROCOTYL® PRIME Acetabular Cup System Traditional 510(k) 510(k) Summary
G. Component and Accessory Compatibility
Tables 1 and 2 show the compatibility of the subject device with previously cleared MicroPort Orthopedics products.
| Table 1: PROCOTYL® PRIME Acetabular Cup System Compatibility | ||
|---|---|---|
| -------------------------------------------------------------- | -- | -- |
| 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 |
| 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® I/O Shells |
- Metal femoral heads in K021349, K004043 and K051348 were originally cleared for use with metal-metal 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.
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Image /page/7/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 underneath. Below the logo is the text "MicroPort Orthopedics Inc."
| 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 | PROFEMUR HIP SYSTEM MODULAR NECKS |
| K100866 | PROFEMUR HIP SYSTEM MODULAR |
| 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 PROCOTYL® PRIME Acetabular Cup System instrumentation includes reamers, trial shells, trial liners, impactors and impactor handles, extraction instruments, and screw instruments. The PROCOTYL® 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/8/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 with a red diamond shape in the center. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below the entire 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. Worst-case device was selected based on product, density, size, and worst case for Ethylene Oxide sterilization. Selected devices were LINEAGE® Acetabular Poly Liner (K002149), LINEAGE® Ceramic Head (K893685).
I. Conclusions
The substantial equivalence of the PROCOTYL® PRIME Acetabular Cup System is adequately supported by the substantial equivalence information, materials information, and nonclinical testing data provided within this premarket notification.