(414 days)
There is no Reference Device(s) K/DEN number in the text provided.
No
The device description and performance studies focus on the mechanical properties and materials of the hip implant components, with no mention of AI or ML technology.
Yes.
The device is an implantable prosthetic used to replace the hip joint, providing a therapeutic solution for painful and disabling conditions.
No.
The device is an implantable orthopedic prosthesis (an artificial hip joint system) intended to replace the hip joint. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components like an acetabular cup, insert, heads, and screws, which are hardware. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a hip prosthesis system intended for surgical implantation to replace a damaged hip joint. This is a surgically implanted medical device, not a device used for testing biological samples outside the body.
- Intended Use: The intended use clearly states the device is for replacing the hip joint in patients with various hip conditions. This is a therapeutic intervention, not a diagnostic test.
Therefore, based on the provided information, the Plasmafit Pro Acetabular Cup System and Vitelene Insert is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint.
The devices are intended for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral ephiphysis
- Patients suffering from disability due to previous fusion .
- Patients with acute femoral neck fractures ♥
Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.
Product codes
OQG, LPH, JDI, OQH, LWJ, LZO, OQI
Device Description
Aesculap Plasmafit Pro Acetabular Cup System and Vitelene Insert is a modular hip prostheses system intended to be used in conjunction with a prosthetic femoral head and hip stem in total hip arthroplasty.
Aesculap Plasmafit Pro consists of a cementless titanium acetabular cup, a highly crosslinked (B-75 kGv) ultra-high molecular weight polyethylene (UHMW-PE) vitamin E insert, 40mm Biolox® delta, 40mm ISODUR® heads and optional titanium screws.
The hemispherical titanium cup with a slightly flattened dome is coated with a titanium plasma spray on the outer surface which aims to provide a high level of primary stability with its rough finish. Plasmafit Pro cups are available in three (3) similar designs only varying in the number of holes (0, 3, 5/7) around the apex. The number of holes are adapted for optional anchoring 6.5mm diameter titanium alloy screws that may be used to ensure primary stability. Plasmafit Pro anchoring screws are an option available separately in sizes 16mm to 68mm lengths.
Vitelene is designed with a taper-fit to the interior surface of Plasmfit Pro cups. The vitamin E insert has been shown to be more resistant to oxidation than conventional UHMWPE. Characterization of the oxidation indices of aged (ASTM F2003) and un-aged Vitelene measured according to ISO 5834-4 did not decrease . Further, Vitelene remains resistant to oxidation after 5 million cycles of wear as demonstrated in testing performed in accordance to ISO 14242.
Plasmafit Pro cups are available in sizes ranging from 40mm - 70mm.
Plasmafit Pro Acetabular Cup System and Vitelene insert may be used with Aesculap Biolox® delta and ISODUR® (CoCrMo) 40mm ball heads along with the following cleared compatible components: Aesculap Hip Implant Systems Excia, Metha, Prevision, and Unisyn and cleared Aesculap femoral heads: Biolox® Option, Biolox® Forte, Biolox® Delta, and CoCrMo to offer several interoperative implant options taking into consideration different patient bone conditions.
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
Not Found
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
Non-clinical testing was performed to demonstrate that Plasmafit Pro Acetabular Cup and Vitelene Insert System is substantially equivalent to other predicate devices. In addition, testing was performed where applicable per FDA Guidance documents:
- "Testing of Metallic Plasma Spraved Coating on Orthopedic Implant to Support . Reconsideration of Postmarket Surveillance";
- "Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone . Cement"
- "Testing Non-Articulation, "Mechanically Locked," Modular Implant Components ●
Testing demonstrated that the Plasmafit Pro Acetabular Cup System and Vitelene Insert is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Excia Total Hip System (Aesculap - K042344), Excia Total Hip System (Aesculap K061699), EXp Acetabular Shell Insert (StelKast, Inc. K094035), Mectacer 40mm Biolox Delta Heads (K11215), Mpact 40mm Ball Heads (K103721) t
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) Premarket Notification
Plasmafit Pro Acetabular Cup and Vitelene Insert
Page 1 of 3
510(k) SUMMARY (as required by 21 CFR 807.92)
Plasmafit Pro Acetabular Cup System and Vitelene Insert
October 30, 2013
COMPANY:
Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034
Establishment Registration Number: 3005673311
OCT 3 0 2013
CONTACT:
Julie Tom Wing 610-984-9147 (phone) 610-791-6882 (fax) julie.tomwing@aesculap.com
TRADE NAME:
Plasmafit Pro Acetabular Cup System and Vitelene Insert
COMMON NAME:
Acetabular Cup and Insert
CLASSIFICATION NAME(s):
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis;
Hip joint metal/polymer semi-constrained cemented prosthesis;
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis;
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
REGULATION NUMBER: 888.3358; 888.3350; 888.3360; 888.3353
| CLASSIFICATION | |
|---|---|
| PRODUCT CODE(S): | OQG |
| SUBSEQUENT | |
|---|---|
| PRODUCT CODE(S): | LPH; JDI; OQH; LWJ; LZO; OQI |
1
K122783
Page 2 of 3
DEVICE DESCRIPTION
Aesculap Plasmafit Pro Acetabular Cup System and Vitelene Insert is a modular hip prostheses system intended to be used in conjunction with a prosthetic femoral head and hip stem in total hip arthroplasty.
Aesculap Plasmafit Pro consists of a cementless titanium acetabular cup, a highly crosslinked (B-75 kGv) ultra-high molecular weight polyethylene (UHMW-PE) vitamin E insert, 40mm Biolox® delta, 40mm ISODUR® heads and optional titanium screws.
The hemispherical titanium cup with a slightly flattened dome is coated with a titanium plasma spray on the outer surface which aims to provide a high level of primary stability with its rough finish. Plasmafit Pro cups are available in three (3) similar designs only varying in the number of holes (0, 3, 5/7) around the apex. The number of holes are adapted for optional anchoring 6.5mm diameter titanium alloy screws that may be used to ensure primary stability. Plasmafit Pro anchoring screws are an option available separately in sizes 16mm to 68mm lengths.
Vitelene is designed with a taper-fit to the interior surface of Plasmfit Pro cups. The vitamin E insert has been shown to be more resistant to oxidation than conventional UHMWPE. Characterization of the oxidation indices of aged (ASTM F2003) and un-aged Vitelene measured according to ISO 5834-4 did not decrease . Further, Vitelene remains resistant to oxidation after 5 million cycles of wear as demonstrated in testing performed in accordance to ISO 14242.
Plasmafit Pro cups are available in sizes ranging from 40mm - 70mm.
Plasmafit Pro Acetabular Cup System and Vitelene insert may be used with Aesculap Biolox® delta and ISODUR® (CoCrMo) 40mm ball heads along with the following cleared compatible components: Aesculap Hip Implant Systems Excia, Metha, Prevision, and Unisyn and cleared Aesculap femoral heads: Biolox® Option, Biolox® Forte, Biolox® Delta, and CoCrMo to offer several interoperative implant options taking into consideration different patient bone conditions.
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for Aesculap Implant Systems Plasmafit Pro Acetabular Cup. Vitelene insert, optional titanium screws and 40mm Biolox® and 40mm ISODUR® femoral heads.
2
Plasmafit Pro Acotabular Cup and Vitelene Insert
K122783
Page 3 of 3
INDICATIONS FOR USE
The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint.
The devices are intended for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis. . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral . ephiphysis
- . Patients suffering from disability due to previous fusion
- Patients with acute femoral neck fractures .
Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the Plasmafit Pro Acetabular Cup System and Vitelene insert is substantially equivalent to:
- . Excia Total Hip System (Aesculap - K042344)
- Excia Total Hip System (Aesculap K061699) .
- EXp Acetabular Shell Insert (StelKast, Inc. K094035) .
- Mectacer 40mm Biolox Delta Heads (K11215) .
- Mpact 40mm Ball Heads (K103721) t
TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s)}
Aesculap Implant Systems Plasmafit Pro Acetabular Cup and Vitelene Insert is an acetabular cup system that is substantially equivalent to the predicate devices previously cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to predicate devices through comparison of indications for use, design, material composition, function and range of sizes.
PERFORMANCE DATA
As recommended by the FDA Guidance for Industry and FDA Staff - Non-clinical testing was performed to demonstrate that Plasmafit Pro Acetabular Cup and Vitelene Insert System is substantially equivalent to other predicate devices. In addition, testing was performed where applicable per FDA Guidance documents:
- "Testing of Metallic Plasma Spraved Coating on Orthopedic Implant to Support . Reconsideration of Postmarket Surveillance";
- "Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone . Cement"
- "Testing Non-Articulation, "Mechanically Locked," Modular Implant Components ●
Testing demonstrated that the Plasmafit Pro Acetabular Cup System and Vitelene Insert is substantially equivalent to the 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the logo is a stylized image of an 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
October 30, 2013
Aesculap Implant Systems, Incorporated Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K122783
Trade/Device Name: Plasmafit Pro Acetabular Cup System and Vitelene Insert Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: OQG, LPH, JDI, OQH, LWJ, LZO, OQI Date: October 24, 2013 Receiver: October 28, 2013
Dear Ms. Julie Tom Wing:
.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 - Ms. Julie Tom Wing
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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
K122783 510(k) Number:
Device Name: Plasmafit Pro Acetabular Cup System and Vitelene Insert
Indications for Use:
The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint.
The devices are intended for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral ephiphysis
- Patients suffering from disability due to previous fusion .
- Patients with acute femoral neck fractures ♥
Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.
Prescription Use X and/or Over-the-Counter Use (per 21 CFR 801.109)
(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