(280 days)
Not Found
No
The document describes a mechanical medical device (acetabular insert and cup system) and its materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is an acetabular insert for hip replacement, which is a medical procedure used to treat significantly impaired joints and other musculoskeletal conditions, thereby directly addressing a health problem. This falls under the definition of a therapeutic device.
No
Explanation: This device is an acetabular insert for hip replacement surgery, falling under orthopedic implants. Its intended use is to replace or repair damaged hip joints, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of a titanium alloy shell and a polyethylene liner, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing or revising hip joints due to various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a physical implant (titanium alloy shell and polyethylene liner) designed to be surgically placed in the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a medical device, specifically a surgical implant for orthopedic use.
N/A
Intended Use / Indications for Use
The Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications:
- A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
- F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn, TaperSet, and CS2 femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH, OQG, LZO, OQI, KWL, KWY, LWJ, JDI, OQH
Device Description
The Consensus CS2™ Acetabular Cup System consists of a titanium alloy shell (ASTM F620 or F136) and a polyethylene liner (ASTM F648). The system is compatible with the femoral components of all cleared hip systems manufactured by Consensus Orthopedics, Inc.: Consensus Hip System (CHS), TaperSet Hip System (THS), CS2 Hip System (CS2HS), and UniSyn Hip System (UniSyn). The CS2 Acetabular Cup System can be used with the CoCr, zirconia, or Biolox delta femoral heads currently marketed by Consensus and with 22mm, 32mm, and 36mm inner diameters. The liners are available in either neutral or hooded versions and with either standard or lateral offsets. The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The shell comes with or without holes for additional screw fixation. The new acetabular liners will be made from UHMPWE that contains vitamin E (a-tocopherol).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, Femoral head
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing and analysis were provided, including bench testing, material characterization, and biocompatibility testing. Bench testing of the new stem design included wear testing of the worst case acetabular insert, in addition to disassembly testing which included push-out, and torque-out tests. All of the observed results indicate that the VitalitE Acetabular Insert is substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.
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.
K100933, K070061, K021466, K122773, K094035, K112802
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
r,
Page 1 of 3
2. 510(k) SUMMARY
DEC 1 7 2013
| Sponsor Name: | Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills, CA 95762 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Matthew M. Hull, RAC
Phone: (916) 355-7156/ Fax: (916) 355-7190
mhull@consensusortho.com |
| Date Prepared: | 16 December, 2013 |
| Trade Name: | VitalitE Acetabular Insert for the CS2™ Acetabular Cup System |
| Common Name: | Vitamin E Cross Linked Polyethylene, Acetabular Insert |
| Device Classification: | Class II |
| Classification(s): | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis: 21 CFR 888.3358, Product Codes LPH & OQG. |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis: 21 CFR 888.3353, Product Codes
LZO & OQI. |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis:
21 CFR 888.3360, Product Code KWL. |
| | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented
prosthesis: 21 CFR 888.3390, Product Code KWY. |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis:
21 CFR 888.3360, Product Code LWJ. |
| | Hip joint metal/polymer semi-constrained cemented prosthesis: 21 CFR
888.3350, Product Codes JDI & OQH. |
| | |
Device Description:
The Consensus CS2™ Acetabular Cup System consists of a titanium alloy shell (ASTM F620 or F136) and a polyethylene liner (ASTM F648). The system is compatible with the femoral components of all cleared hip systems manufactured by Consensus Orthopedics, Inc.: Consensus Hip System (CHS), TaperSet Hip System (THS), CS2 Hip System (CS2HS), and UniSyn Hip System (UniSyn). The CS2 Acetabular Cup System can be used with the CoCr, zirconia, or Biolox delta femoral heads currently marketed by Consensus and with 22mm, 32mm, and 36mm inner diameters. The liners are available in either neutral or hooded versions and with either standard or lateral offsets. The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The
1
K130652
shell comes with or without holes for additional screw fixation. The new acetabular liners will be made from UHMPWE that contains vitamin E (a-tocopherol).
Indications for Use:
The VitalitE Acetabular Insert for the Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications:
A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
- F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
Acetabular components are indicated for cemented and cementless use.
Consensus femoral stems are indicated for cemented and cementless use.
UniSyn. TaperSet, and CS2 femoral stems are indicated for cementless use only.
HA coated implants are indicated for cementless use only.
Substantial Equivalence:
Technological Characteristics/ Substantial Equivalence:
The new VitalitE Acetabular Insert for the CS2 Acetabular Cup System is identical in design to the cross-linked UHMWPE acetabular insert previously cleared for Consensus in the following 510(k) s: K021466, K070061, and K100933. The vitamin E poly used in the new Consensus CS2 insert is identical to the poly cleared for the StelKast EXp acetabular liner in K094035 and K122773 (with the exception of the radiation dosing level).
Based on the material, characterization data, geometry and mechanical testing, the new VitalitE CS2 Hip is substantially equivalent to legally marketed predicates.
Legally Marketed Devices to which Substantial Equivalence is claimed:
K100933 (Consensus Orthopedics, Inc.): Consensus CS2 Plus Acetabular Inserts (lateralized) K070061 (Hayes Medical, Inc.): Consensus Hip System 36mm Femoral Head & Acetabular Insert K021466 (Haves Medical, Inc.): Cross Linked Polyethylene Acetabular Insert K122773 (SteKast, Inc.): Cross-Over Acetabular Shell and Liner (lateralized) K094035 (StelKast, Inc.): EXp Acetabular Shell Liner K112802 (Pipeline Orthopedics, Inc.): Pipeline Total Hip System
Non-Clinical Performance Data:
Non-clinical testing and analysis were provided, including bench testing, material characterization, and biocompatibility testing. Bench testing of the new stem design included wear testing of the worst case acetabular insert, in addition to disassembly testing which included push-out, and torque-out tests.
2
All of the observed results indicate that the VitalitE Acetabular Insert is substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.
:
·
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the 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
December 17, 2013
Consensus Orthopedics, Incorporated Matthew M. Hull. RAC Director, Ouality Systems & Regulatory Affairs 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762
Re: K130652
Trade/Device Name: VitalitE Acetabular Insert for the CS2" 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: OQG, LPH, LZO, OQI, KWL, KWY, LWJ, JDI, OQH Dated: November 4, 2013 Received: November 5, 2013
Dear Mr. Hull:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 -Matthew M. Hull, RAC
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.
If you desire specific advice for vour 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/Industrv/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 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.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K130652
Device Name: VitalitE Acetabular Insert for the CS2TM Acetabular Cup System
Indications for Use:
The Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications:
- A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
- F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn, TaperSet, and CS2 femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.
Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 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)
Elizabeth L. Frank -S · 2013.12.13 16:08:40 -05'00'