(77 days)
Not Found
No
The device description focuses on the materials and mechanical components of a hip implant system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a hip implant system indicated for rehabilitating hip joints affected by various conditions such as osteoarthritis and fractures, which falls under the definition of a therapeutic device.
No
The POLARCUP® Dual Mobility System is an implantable medical device designed to replace or repair components of the hip joint. It is a treatment device, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical components made of stainless steel, titanium, and polyethylene, which are hardware.
Based on the provided text, the POLARCUP® Dual Mobility System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The POLARCUP® Dual Mobility System is a medical device intended for surgical implantation to replace or repair a damaged hip joint. Its purpose is mechanical and structural, not diagnostic testing of biological samples.
The description clearly outlines its use in surgical procedures for treating various hip joint conditions and its components are materials designed for implantation within the body.
N/A
Intended Use / Indications for Use
The POLARCUP® Dual Mobility System is indicated for:
- All forms of osteoarthritis .
- Dislocation risks .
- Progressive loss of function of the hip joint as a result of a degenerative post-. traumatic or inflammatory / rheumatic destruction of the joint
- . Femoral head necrosis
- Proximal femoral fractures (especially femoral neck) .
- . Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement
The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
Product codes (comma separated list FDA assigned to the subject device)
LPH, KWY
Device Description
The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.
Shell Component: The POLARCUP® shell, is manufactured from stainless steel INOX M30NW according to ISO 5832-9:1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel, and is available in three configurations:
- Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, with pegs and two flanges, uncemented use: allows for implantation with no pegs and no flanges, with no pegs and contoured flanges, screws in flanges but with no pegs, and two impacted pegs and two screws in flanges
- Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, without pegs and flanges, uncemented use)
- Stainless steel, mirror polished, without pegs and flanges, cemented use
Note: the pure Titanium coating found in the uncemented versions is a Titanium alloy according to ISO 5832-2:1999. Implants for Surgery -Metallic Materials - Part 2: Unalloyed Titanium.
The POLARCUP® shell is available in 13 sizes for each of the titaniumcoated versions for uncemented use, ranging in diameter from 43 mm to 67 mm. The mirror-polished version for cemented use is available in 11 sizes, ranging in diameter from 43 mm to 63 mm.
Cortical Screws and Impacted Pegs: Cortical screws and impacted pegs, both made of stainless steel INOX 316LVM according to ISO 5832-1:1997, Implants for surgery -- Metallic materials -- Part 9: Wrought Stainless Steel, are available for use with the POLARCUP® shell version with pegs and flanges for uncemented use. The cortical screws are 4.5 mm in diameter and available in 6 different lengths ranging from 40 mm to 60 mm. The impacted pegs are available in a single length of 13 mm.
Liner Component: The POLARCUP® liner component is a polyethylene insert, specifically Ultra-High Molecular Weight Polyethylene (UHMW PE) according to ISO 5834-2:1998, Implants for Surgery -- Ultra-High-Molecular-Weight Polyethylene - Part 2 : Moulded Forms, that retains the femoral head and moves freely in the POLARCUP® shell, allowing increased mobility and stability. The liner component is available in two internal joint diameters. 22 mm and 28 mm. The 22 mm diameter liner is available in 13 different sizes of spherical external radius of curvature whereas the 28 mm diameter liner is available in 11 different sizes of spherical external radius of curvature (to ensure a minimal thickness of 6.5 mm according to EN 12563).
The POLARCUP® Dual Mobility System may be used with the following components provided that they are legally marketed in the US and meet these specifications:
- Ball Heads: made of CoCrMo, ceramic or stainless steel, with diameters . of 22 or 28 mm
- Femoral Stems: polished or electro-polished necks .
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 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)
Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.
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.
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
APR 16 2007
D.0 Premarket Notification 510(k) Summary
D.1 Submitter Information
Company Name and Address:
PLUS ORTHOPEDICS AG Erlenstraße 4a CH-6343 Rotkreuz Switzerland
Contact Name:
Pamela J. Weagraff, Principal Consultant Quintiles Consulting 18 Bridie Lane Norfolk, MA 02056
Telephone: 508-528-1745 Facsimile: 978-752-1225 E-mail: pamela.weagraff@quintiles.com
Date Prepared: January 23, 2007
D.2 Name of Device
- 2.1 Trade Name: POLARCUP® Dual Mobility System
- 2.2 Common Name: Acetabular Component
- 2.3 Classification Name and Reference:
Title 21 Code of Federal Regulation (CFR), Part 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Product Code: LPH Title 21, CFR, Part 888.3390, Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis; Product Code: KWY
Substantial Equivalence Claimed to Predicate Device D.3
Biomet® Tri-Polar Systems, K991990
Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007
1
D.4 Device Description
The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.
4.1 Shell Component
The POLARCUP® shell, is manufactured from stainless steel INOX M30NW according to ISO 5832-9:1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel, and is available in three configurations:
- � Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, with pegs and two flanges, uncemented use: allows for implantation with no pegs and no flanges, with no pegs and contoured flanges, screws in flanges but with no pegs, and two impacted pegs and two screws in flanges
- . Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, without pegs and flanges, uncemented use)
- . Stainless steel, mirror polished, without pegs and flanges, cemented use
Note: the pure Titanium coating found in the uncemented versions is a Titanium alloy according to ISO 5832-2:1999. Implants for Surgery -Metallic Materials - Part 2: Unalloyed Titanium.
The POLARCUP® shell is available in 13 sizes for each of the titaniumcoated versions for uncemented use, ranging in diameter from 43 mm to 67 mm. The mirror-polished version for cemented use is available in 11 sizes, ranging in diameter from 43 mm to 63 mm.
4.2 Cortical Screws and Impacted Pegs
Cortical screws and impacted pegs, both made of stainless steel INOX 316LVM according to ISO 5832-1:1997, Implants for surgery -- Metallic materials -- Part 9: Wrought Stainless Steel, are available for use with the POLARCUP® shell version with pegs and flanges for uncemented use. The cortical screws are 4.5 mm in diameter and available in 6 different lengths ranging from 40 mm to 60 mm. The impacted pegs are available in a single length of 13 mm.
2
4.3 Liner Component
The POLARCUP® liner component is a polyethylene insert, specifically Ultra-High Molecular Weight Polyethylene (UHMW PE) according to ISO 5834-2:1998, Implants for Surgery -- Ultra-High-Molecular-Weight Polyethylene - Part 2 : Moulded Forms, that retains the femoral head and moves freely in the POLARCUP® shell, allowing increased mobility and stability. The liner component is available in two internal joint diameters. 22 mm and 28 mm. The 22 mm diameter liner is available in 13 different sizes of spherical external radius of curvature whereas the 28 mm diameter liner is available in 11 different sizes of spherical external radius of curvature (to ensure a minimal thickness of 6.5 mm according to EN 12563).
The POLARCUP® Dual Mobility System may be used with the following components provided that they are legally marketed in the US and meet these specifications:
- Ball Heads: made of CoCrMo, ceramic or stainless steel, with diameters . of 22 or 28 mm
- Femoral Stems: polished or electro-polished necks .
D.5 Intended Use
The POLARCUP® Dual Mobility System is indicated for:
- . All forms of osteoarthritis
- . Dislocation risks
- Progressive loss of function of the hip joint as a result of a degenerative post-. traumatic or inflammatory / rheumatic destruction of the joint
- . Femoral head necrosis
- Proximal femoral fractures (especially femoral neck) .
- . Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement
The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
D.6 Predicate Device Comparison of Indications for Use / Intended Use and Technical Characteristics
The comparison of the POLARCUP® Dual Mobility System was based on a review of the Design Control documentation, relevant aspects of which are included in the company's 510(k) Premarket Notification, and information concerning the predicate device that was obtained from the predicate device manufacturer's web site. The comparison considered technical characteristics and the indications for use / intended use.
Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007
3
D.7 Performance Data
- 7.1 Performance Standards (Section 514 Compliance): no applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act, for either hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis or hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
- 7.2 The POLARCUP® Dual Mobility System does conform to the following FDA recognized standards:
7.2.1 Sterility
ISO 11137-1:2006, Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2, 2006, Sterilization of health care products --Radiation -- Part 2: Establishing the sterilization dose
7.2.2 Materials
ISO 5832-9:1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel
ISO 5832-2:1999, Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium
ISO 5832-1:1997, Implants for surgery -- Metallic materials -- Part 9: Wrought Stainless Steel
ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2 : Moulded Forms
- 7.3 Performance Testing: Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.
D.8 Conclusion:
The information and data provided in this 510(k) Premarket Notification establish that the POLARCUP® Dual Mobility System is substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Plus Orthopedics AG % Quintiles Consulting Ms. Pamela J. Weagraff, MBA, RAC 18 Bridie Lane Norfolk, Massachusetts 02056
APR 1 6 2007
Re: K070278
Trade/Device Name: POLARCUP® Dual Mobility 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, KWY Dated: January 23, 2007 Received: January 29, 2007
Dear Ms. Weagraff:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
5
Page 2 - Ms. Pamela J. Weagraff
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Brye Kup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
ODE Indications Statement
510(k) Number (if known): Unknown
Device Name: POLARCUP® Dual Mobility System
Indications for Use:
The POLARCUP® Dual Mobility System is indicated for:
- All forms of osteoarthritis .
- Dislocation risks .
- Progressive loss of function of the hip joint as a result of a degenerative post-. traumatic or inflammatory / rheumatic destruction of the joint
- . Femoral head necrosis
- Proximal femoral fractures (especially femoral neck) .
- . Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement
The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
Prescription Use: X (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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michale Buchman
Division Sign-up),
Division of Ger. vol. Restorative,
and A
510(k, ...K070278
Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007
Company Confidential Page 9 of 77