(102 days)
The HELICON™ Hip System is designed for total hip arthroplasty.
The indications for use are:
- Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- Proximal femoral fractures.
- Avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures.
- 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
The HELICON™ hip stem is indicated for cementless use. The HELICON™ acetabular shell component is indicated for cemented or cementless use.
The HELICON Hip System (HHS) is a porous-coated, semi-constrained, hip prosthesis designed for either primary or revision hip arthroplasty. The HHS includes a femoral stem, a CoCr femoral head, non-crosslinked UHMWPE insert, acetabular shell and bone screws.
The HHS stem is a monolithic, titanium alloy, tapered hip stem available with a proximal CPTi plasma porous coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes ranging from 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. HHS stems are compatible with the HHS CoCr femoral head and HHS acetabular insert. The HHS CoCr head is highly polished and available in multiple offsets and diameters (22, 28, and 32mm). The HHS acetabular components include a titanium alloy shell and a mating UHMWPE insert. The shell is a hemispherical design, is available with or without screw holes, and employs a CPTi beaded, porous coating. The UHMWPE insert is available in 20° hooded or nonhooded (neutral) configurations in inner diameters of 22, 28, and 32mm. Titanium alloy bone screws are available for additional fixation.
The provided text describes a Premarket Traditional 510(k) Notification for the HELICON Hip System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.
Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this type of submission. The submission explicitly states: "No additional nonclinical bench testing was deemed necessary over that used in support of the predicates based on identical design and materials." and "All of the observed results for the predicate TaperSet Hip System had been found substantially equivalent prior to devices currently marketed. The subject Helicon Hip System is identical in material and design to that of the TaperSet Hip System."
Below is an attempt to address the request based on the information provided, highlighting where information is not applicable due to the nature of a 510(k) for substantial equivalence.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The HELICON Hip System (HHS) demonstrates acceptance by establishing substantial equivalence to legally marketed predicate devices. This means that its acceptance criteria are implicitly those that the predicate devices met, and the "study" proving this is a comparative analysis against the predicates across various technological characteristics and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim based on identical design and materials to predicates, the acceptance criteria are inferred to be the performance standards met by the predicate devices. The reported device performance for HHS is asserted to be identical to these predicates due to the "identical material, characterization data, geometry and mechanical testing."
| Acceptance Criteria (Inferred from Predicates) | Reported Device Performance (for HELICON Hip System) |
|---|---|
| Material Composition: Identical material specifications (e.g., Titanium alloy, CoCr, UHMWPE) as predicate components. | Identical: HHS implant components use identical materials as predicate components (TaperSet Hip System femoral stem, CoCr femoral heads, UHMWPE inserts, acetabular shell, bone screws). |
| Design Geometry: Identical design construct features, including dual wedge geometry, neck shaft angle (135°), Morse taper trunnion, hemispherical shell design, etc., as predicate components. | Identical: HHS implant components use identical design construct features as predicate components (e.g., locking mechanisms of the polyethylene insert to the metal shell and the exterior coatings). |
| Mechanical Performance: - Distal and proximal stem fatigue testing (worst-case stem). - Range of Motion analysis. - CPTi plasma sprayed and CPTi beaded metallic coating characterization (per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"). - CPTi plasma spray characterization (per "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants..."). - Polyethylene insert retention mechanism testing. - Bone screw mechanical strength testing. - Modular connection analyses (fretting and corrosion of metallic femoral heads). - Pin-on-flat testing of non-crosslinked UHMWPE/CoCr material combination. | Met by Predicate Devices; Asserted for HHS: All predicate bench testing results, covering the items listed in the criteria, were found substantially equivalent and are directly applicable to HHS due to identical design and materials. "No additional nonclinical bench testing was deemed necessary." "Therefore, the subject device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates." |
| Porous Coating Definition: CPTi plasma sprayed coating and CPTi beaded coating characterizations meet regulatory definition of porous coating for hip construct per 21 CFR 888.3358. | Met by Predicate Devices; Asserted for HHS: Both the CPTi plasma sprayed coating and the CPTi beaded coating characterizations meet the regulatory definition of porous coating for the hip construct per 21 CFR 888.3358. |
| Indications for Use: Consistent with the indications for use of the predicate devices. | Consistent: The indications for use for the HHS are identical to those of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. There was no new "test set" in the traditional sense for the HELICON Hip System. The assessment relies on the existing performance data and characterizations of the predicate devices.
- Data Provenance: The data provenance is from the non-clinical bench testing conducted for the predicate devices, specifically those associated with Consensus Orthopedics, Inc. (COI) and U.S. Medical Products, Inc. This would be retrospective as the testing has already been completed and reviewed by the FDA for the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission does not involve a clinical study requiring expert ground truth for a test set. The "ground truth" for the performance of the HELICON Hip System is established by its direct identity in materials and design to the already cleared predicate devices, whose performance characteristics were previously vetted by the FDA through their own respective 510(k) clearances.
4. Adjudication Method for the Test Set
Not applicable. There was no new test set requiring adjudication in this 510(k) submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" is based on the non-clinical bench testing results and material/design characterization data from the predicate devices. This data was previously accepted by the FDA as sufficient to demonstrate the safe and effective performance of those predicate devices. For the HELICON Hip System, the ground truth is its identicality to these well-characterized predicates.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an orthopedic implant 510(k) submission based on substantial equivalence to predicates.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this type of device submission.
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TGM Medical, Inc Premarket Traditional 510(k) Notification: HELICON Hip System
Page 1 of 3
| 510(k) SUMMARY | K 111472 | |
|---|---|---|
| Sponsor Name: | TGM Medical, Inc.5145 Golden Foothill Parkway, Suite 175 & 180El Dorado Hills, CA 95762 | SEP - 6 20 |
| 510(k) Contact: | Dennis CraneEmerson Consultants, Inc12701 Whitewater Drive, Suite 120Minnetonka, MN 55343Phone: 952.374.6012 / Fax: 952.374.6001dennisc@emersonconsultants.com | |
| Date Prepared: | August 29, 2011 | |
| Trade Name: | HELICON Hip System (HHS) | |
| Common Name: | Porous-coated hip prosthesis for cementless use | |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis (21 CFR 888.3358, Class II device,Product Code LPH). |
Device Description:
The HELICON Hip System (HHS) is a porous-coated, semi-constrained, hip prosthesis designed for either primary or revision hip arthroplasty. The HHS includes a femoral stem, a CoCr femoral head, non-crosslinked UHMWPE insert, acetabular shell and bone screws.
The HHS stem is a monolithic, titanium alloy, tapered hip stem available with a proximal CPTi plasma porous coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes ranging from 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. HHS stems are compatible with the HHS CoCr femoral head and HHS acetabular insert. The HHS CoCr head is highly polished and available in multiple offsets and diameters (22, 28, and 32mm). The HHS acetabular components include a titanium alloy shell and a mating UHMWPE insert. The shell is a hemispherical design, is available with or without screw holes, and employs a CPTi beaded, porous coating. The UHMWPE insert is available in 20° hooded or nonhooded (neutral) configurations in inner diameters of 22, 28, and 32mm. Titanium alloy bone screws are available for additional fixation.
Indications for Use:
The HELICON™ Hip System is designed for total hip arthroplasty.
The indications for use are:
- A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
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TGM Medical, Inc Premarket Traditional 510(k) Notification: HELICON Hip System
Page 2 of 3
- 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
The HELICON™ hip stem is indicated for cementless use. The HELICON™ acetabular shell component is indicated for cemented or cementless use.
Substantial Equivalence:
Technological Characteristics/Substantial Equivalence:
The HHS is equivalent to predicate systems in design geometry, materials, performance testing and indications for use. Consensus Orthopedics, Inc. (COI) licensed their previously cleared hip components to TGM Medical, Inc. The hip components consist of the previously cleared TaperSet Hip System femoral stem (K102399), CoCr femoral heads (K922561, K960339, and K960156), UHMWPE inserts (K922561 and K020153), acetabular shell (K922561) and titanium bone screws (K922561). The HHS hip components therefore have the same technological characteristics to those used in the Consensus Taper Set Hip System. Based on the identical material, characterization data, geometry and mechanical testing, the HHS system is substantially equivalent to legally marketed predicates (Table 2.1).
| 510(k)Number | Trade Name | 510(k) holder | 510(k)Release Date |
|---|---|---|---|
| K922561 | Consensus Total Hip System | U.S. Medical Products, Inc. | 07/21/1993 |
| K960339 | Consensus 22mm CoCrMo FemoralHead | U.S. Medical Products, Inc. | 02/21/1996 |
| K960156 | Consensus 32mm CoCrMo FemoralHead | U.S. Medical Products, Inc. | 02/21/1996 |
| K960340 | Consensus Apex Dome Hole Plug | U.S. Medical Products, Inc. | 03/15/1996 |
| K102399 | Consensus TaperSet Hip System | Consensus Orthopedics, Inc. | 12/02/2010 |
| K100933 | CS2 Plus Acetabular Insert | Consensus Orthopedics, Inc. | 10/06/2010 |
| K020153 | Consensus Acetabular Shell, TiCoated | Hayes Medical, Inc. | 04/15/2002 |
Table 2.1: Legally marketed devices to which substantial equivalence is claimed:
Non-Clinical Performance Data:
COI provided rights to reference their 510(k)s and supporting performance testing. The HELICON Hip System (HHS) implant components use the identical materials, design construct features (e.g., including locking mechanisms of the polyethylene insert to the metal shell and the exterior coatings) of the predicate components. No changes were made to the predicate components that required additional testing. The HHS implant components
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TGM Medical. Inc Premarket Traditional 510(k) Notification: HELICON Hip System
Page 3 of 3
-111472
were evaluated using a Failure Modes and Effects Analysis (FMEA). No additional nonclinical bench testing was deemed necessary over that used in support of the predicates based on identical design and materials.
Predicate bench testing included distal and proximal stem fatigue testing of the worst-case stem consistent with the "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses;" Range of Motion analysis; CPTi plasma sprayed and CPTi beaded metallic coating characterization per the "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement;" CPTi plasma spray characterization per the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements;" polyethylene insert retention mechanism testing; and bone screw mechanical strength testing. Additionally, modular connection analyses including fretting and corrosion of the metallic femoral heads for compatibility and pin-on-flat testing of the non-crosslinked UHMWPE/CoCr material combination were also performed. Both the CPTi plasma sprayed coating and the CPTi beaded coating characterizations meet the regulatory definition of porous coating for the hip construct per 21 CFR 888.3358.
All of the observed results for the predicate TaperSet Hip System had been found substantially equivalent prior to devices currently marketed. The subject Helicon Hip System is identical in material and design to that of the TaperSet Hip System. Therefore, the subject device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, with three bars across its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TGM Medical. Inc. % Emerson Consultants. Inc. Mr. Dennis Crane 12701 Whitewater Drive, Suite 120 Minnetonka, Minnesota 55343
SEP - 6 2011
Re: K111472
Trade/Device Name: HELICON Hip System (HSS) 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 Dated: August 3, 2011 Received: August 5, 2011
Dear Mr. Crane:
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
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Page 2 - Mr. Dennis Crane
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric Keith
fs Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1. INDICATIONS FOR USE STATEMENT
K 11472
510(k) Number (if known):
Device Name: HELICON Hip System
Indications for Use:
The HELICON™ Hip System is designed for total hip arthroplasty.
The indications for use are:
- Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic A. arthritis.
- Revision of failed femoral head replacement, cup arthroplasty or other hip B. procedures.
- Proximal femoral fractures. C..
- D. Avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures. E.
- Other indications such as congenital dysplasia, arthrodesis conversion, coxa F. magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
The HELICON™ hip stem is indicated for cementless use. The HELICON™ acetabular shell component is indicated for cemented or cementless use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)
for M Melkeem
(Division Sign Division signical (Division Sign-Dff)
Division of Surgical, Orthopedic, Orthopedic,
Controlectorerive Devices Division of Surgion in Surgices
and Restorative Devices and Restorative Devices
510(k) Number -
§ 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.