(270 days)
Not Found
No
The description focuses on the materials and mechanical components of a modular hip reconstruction system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for the reconstruction of the proximal femur in hip revision surgery or in the case of a bone tumor, which are therapeutic interventions.
No
Explanation: The Pantheon PFR System is a modular system for the reconstruction of the proximal femur, indicating it is an orthopedic implant for treatment, not a device used for diagnosis. Its description and intended use focus on replacing bone and joint structures, not on identifying conditions.
No
The device description clearly lists numerous hardware components made of various materials (Ti6A14V, CoCrMo, ceramic, UHMWPE) that constitute the Pantheon PFR System. The performance studies also focus on the mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the reconstruction of the proximal femur in surgical procedures. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The device is described as a modular system of implants (femoral bodies, heads, shafts, cups, screws, etc.) made of materials like titanium and cobalt-chromium. These are components designed to be surgically implanted to replace bone and joint structures.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
- Performance Studies: The performance studies listed are related to the mechanical properties and durability of the implants (fatigue, corrosion, wear, etc.), which are relevant for surgical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the reconstruction of the proximal femur in the case of severe proximal femoral bone loss in hip revision surgery (due to infection, fracture, failed THA) or in the case of a bone tumor.
The FIXA Ti-Por cup is intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI, LZO, MBL
Device Description
The Pantheon PFR System is manufactured of Ti6A14V (except for femoral heads which are made of CoCrMo or ceramic and acetabular inserts made of cross-linked UHMWPE) and includes various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The Pantheon PFR System consists of:
- Pantheon Proximal Bodies made of Ti6Al4V Alloy additively manufactured .
- o System compatibility
- . A 12/14 connection taper to connect CoCrMo Alloy or Biolox Delta Ceramic Femoral Heads
- . A female conical taper to connect Pantheon Shaft or intramedullary Pantheon Salvage Stem
- . A through-hole for screw to lock Pantheon Shaft or intramedullary Pantheon Salvage Stem
- For Pantheon Proximal Body Flat only: lateral threaded holes for Pantheon l Salvage Plate Compression Screws
- Size range o
- . Pantheon Proximal Body Flat
- L50mm (Medium, and long), L70mm (Medium, and long) .
- I Pantheon Proximal Body Smooth
- . L50mm (Medium, and long), L70mm (Medium, and long)
- . Pantheon Proximal Body Flat
- o System compatibility
- CoCrMo Alloy Femoral Heads Taper 12/14 ●
- System compatibility о
- Cross-Linked PE Inserts .
- Size range o
- Ø 22m, Ø 28mm, Ø 32mm, Ø 36mm .
- System compatibility о
- Biolox Delta Ceramic Femoral Heads Taper 12/14 .
- o System compatibility
- Cross-Linked PE Inserts .
- Size range O
- Ø 22m, Ø 28mm, Ø 32mm, Ø 36mm .
- o System compatibility
- Pantheon Shaft made of Ti6Al4V Alloy .
- System compatibility o
- A female conical taper to connect intramedullary Pantheon Salvage Stems .
- Size range o
- from 35 mm to 200 mm in 15 mm increments .
- System compatibility o
- Pantheon Bridging Collars made of Ti6Al4V Alloy additively manufactured .
- System compatibility o
- . A female conical taper to connect intramedullary Pantheon Salvage Stems
- Size range o
- . Ø 26m, Ø 30mm, and, Ø 36mm
- System compatibility o
- Pantheon Cylindrical Bridging Collars made of Ti6A14V Alloy additively manufactured ●
- System compatibility
- A female conical taper to connect intramedullary Pantheon Salvage Stems .
- Size range o
- Ø 26 mm, Ø 30 mm, and Ø 36 mm .
- System compatibility
- . Pantheon Salvage Stem (Cemented) made of Ti6Al4V Alloy
- Size range O
- L115 Ø 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22 mm .
- Size range O
- Pantheon Salvage Stem (Uncemented) made of Ti6A14V alloy .
- Size range o
- L115 の 12, 13, 14, 15, 16, 19, 20, 22, 24 mm .
- Size range o
- . Pantheon Proximal Body Locking Screw made of Ti6A14V Alloy
- Size range o
- L50 mm, L70 mm .
- Size range o
- Pantheon Salvage Plate Compression Screws made of Ti6Al4V Alloy ●
- Size range o
- Extra-Short, Short, Medium, Long .
- Size range o
- Pantheon Salvage Plate with Spikes made of Ti6A14V Alloy .
- o Size range
- . L50 mm. L70 mm
- o Size range
- Fixa Ti-Por Cup Acetabular Shells made of Ti6Al4V Alloy additively manufactured .
- o System compatibility
- Cross-Linked PE Inserts l
- . Lateral Holes Plug
- . Titanium Acetabular Screw
- Size range o
- . Size 48, 50, 52, 54, 56, 58, 60, 62, 64
- Titanium Acetabular Screws made of Ti6A14V Alloy .
- o Size range
- . Diam. 6.5 mm from L15 to L50 mm in 5mm increments
- o Size range
- Acetabular Inserts Flat made of Cross-Linked PE .
- Size range o
- Internal Diam. 22, 28, 32, 36 mm .
- Size range o
- Acetabular Inserts 15° Lipped made of Cross-Linked PE .
- Size range o
- . Internal Diam. 28, 32, 36 mm
- Size range o
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing was performed on the Pantheon Proximal Femur Reconstruction (PFR) System:
- Neck Fatigue Testing (ISO 7206-6) ●
- Distal Stem Fatigue Testing (ISO 7206-4:2010)
- Corrosion Testing (ASTM F1875-98) ●
- Post Fatigue Modular Disassembly Testing (ASTM F2009-20, ISO 7206-10:2018) ●
- Taper Disassembly Testing (ASTM F2009-20, ISO 7206-10:2018) ●
- . Axial disassembly between shafts
- Torsional disassembly between shafts .
- Torsional disassembly between shaft and proximal body .
- Range of Motion (EN ISO 21535:2017) .
- Impingement Testing (ASTM F2582-20) ●
- Ceramic Head Burst Testing (ISO 7206-10, ASTM F2345) ●
- . Ceramic Head Fatigue Testing (ISO 7206-10, ASTM F2345)
- Ceramic Head Post-Fatigue Burst Testing (ISO 7206-10, ASTM F2345) ●
- Ceramic Head Disassembly (Pull-Off) Testing (ISO 7206-10, ASTM F2009) ●
- Ceramic Head Rotational Stability (Torque) Testing (ISO 7206-13) ●
- CoCrMo Head Disassembly (Pull-Off) Testing (ASTM F2009-20)
- CoCrMo Head Rotational Stability (Torque) Testing (ISO 7206-13:2016, ISO 7206-10:2018)
- Acetabular Cup Fatigue Testing (ASTM F3090-20) ●
- Insert push-out Testing (ASTM F1820-13)
- . Insert lever out Testing (ASTM F1820-13)
- Insert torque-out Testing (ASTM F1820-13)
- Insert Wear Testing (ISO 14242-1:2014/Amd1:2018, ISO 14242-2:2016)
- Acetabular Screw Torsion (ASTM F543) ●
- Acetabular Screw Driving Torque (ASTM F543) ●
- Acetabular Screw Pull-Out (ASTM F543) ●
- Acetabular Cup Deformation Testing rationale ●
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The geometries and range of available sizes are also similar. The subject and predicate devices are packaged and sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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.
K023087, K040749, K980513, K071535, K112898, K072963, K110940
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
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January 13, 2025
Adler Ortho S.p.A % Mehdi Kazemzadeh-Narbat Director, Regulatory Affairs MCRA, LLC 803 7th Street NW, Floor 3 Washington, District of Columbia 20001
Re: K241059
Trade/Device Name: Pantheon Proximal Femur Reconstruction (PFR) 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, JDI, LZO, MBL Dated: December 9, 2024 Received: December 10, 2024
Dear Mehdi Kazemzadeh-Narbat:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/3 description: The image contains the text "Limin Sun -S" in a large, sans-serif font. The text is black and stands out against a white background. The words are arranged horizontally, with a hyphen separating "Sun" and "S".
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241059
Device Name
Pantheon Proximal Femur Reconstruction (PFR) System
Indications for Use (Describe)
The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the reconstruction of the proximal femur in the case of severe proximal femoral bone loss in hip revision surgery (due to infection, fracture, failed THA) or in the case of a bone tumor.
The FIXA Ti-Por cup is intended for cementless use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
K241059
510(k) Summary
| Device Trade Name: | Pantheon Proximal Femur Reconstruction (PFR) System | ||||
|---|---|---|---|---|---|
| Manufacturer: | Adler Ortho S.p.A | ||||
| 9 Via Dell'Innovazione | |||||
| 20032 Cormano (MI) | |||||
| Italy | |||||
| Contact: | Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA | ||||
| Director, Regulatory Affairs, MCRA LLC | |||||
| 803 7th Street NW, Floor 3 | |||||
| Washington, DC 20001 | |||||
| Office: 202.552.6011 | |||||
| Mobile: 857.222.1125 | |||||
| mkazemzadeh@mcra.com | |||||
| Prepared by: | Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA | ||||
| Director, Regulatory Affairs, MCRA LLC | |||||
| 803 7th Street NW, Floor 3 | |||||
| Washington, DC 20001 | |||||
| Office: 202.552.6011 | |||||
| Date Prepared: | January 13th, 2025 | ||||
| Classifications: | 21 CFR 888.3350, Hip joint metal/polymer semi-constrained cemented prosthesis | ||||
| 21 CFR 888.3353, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis | |||||
| 21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. | |||||
| Class: | II | ||||
| Product Code: | LPH, JDI, LZO, MBL |
5
| Primary Predicate: | Global Modular Replacement System (GMRS®) Proximal
Femoral (K023087) | | | | | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Additional Predicates: | Global Modular Replacement System (GMRS®) Proximal
Femoral (K040749)
M-SPEC Metal Femoral Heads (K980513)
Biolox Delta Ceramic Femoral Heads (K071535)
Delta TT Acetabular System (K112898)
Pinnacle Altrx Polyethylene Acetabular Liner (K072963)
Zimmer® Segmental System Trabecular Metal Proximal Tibial
Component, Trabecular Metal Proximal Femoral Component, and
additional Segment with Male/Female Taper components
(K110940) | | | | | | |
Indications for Use:
The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the reconstruction of the proximal femur in the case of severe proximal femoral bone loss in hip revision surgery (due to infection, fracture, failed THA) or in the case of a bone tumor.
The FIXA Ti-Por cup is intended for cementless use.
Device Description:
The Pantheon PFR System is manufactured of Ti6A14V (except for femoral heads which are made of CoCrMo or ceramic and acetabular inserts made of cross-linked UHMWPE) and includes various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The Pantheon PFR System consists of:
- Pantheon Proximal Bodies made of Ti6Al4V Alloy additively manufactured .
- o System compatibility
- . A 12/14 connection taper to connect CoCrMo Alloy or Biolox Delta Ceramic Femoral Heads
- . A female conical taper to connect Pantheon Shaft or intramedullary Pantheon Salvage Stem
- . A through-hole for screw to lock Pantheon Shaft or intramedullary Pantheon Salvage Stem
- For Pantheon Proximal Body Flat only: lateral threaded holes for Pantheon l Salvage Plate Compression Screws
- Size range o
- . Pantheon Proximal Body Flat
- L50mm (Medium, and long), L70mm (Medium, and long) .
- I Pantheon Proximal Body Smooth
- . L50mm (Medium, and long), L70mm (Medium, and long)
- . Pantheon Proximal Body Flat
- o System compatibility
6
- CoCrMo Alloy Femoral Heads Taper 12/14 ●
- System compatibility о
- Cross-Linked PE Inserts .
- Size range o
- Ø 22m, Ø 28mm, Ø 32mm, Ø 36mm .
- System compatibility о
- Biolox Delta Ceramic Femoral Heads Taper 12/14 .
- o System compatibility
- Cross-Linked PE Inserts .
- Size range O
- Ø 22m, Ø 28mm, Ø 32mm, Ø 36mm .
- o System compatibility
- Pantheon Shaft made of Ti6Al4V Alloy .
- System compatibility o
- A female conical taper to connect intramedullary Pantheon Salvage Stems .
- Size range o
- from 35 mm to 200 mm in 15 mm increments .
- System compatibility o
- Pantheon Bridging Collars made of Ti6Al4V Alloy additively manufactured .
- System compatibility o
- . A female conical taper to connect intramedullary Pantheon Salvage Stems
- Size range o
- . Ø 26m, Ø 30mm, and, Ø 36mm
- System compatibility o
- Pantheon Cylindrical Bridging Collars made of Ti6A14V Alloy additively manufactured ●
- System compatibility
- A female conical taper to connect intramedullary Pantheon Salvage Stems .
- Size range o
- System compatibility
o
- Ø 26 mm, Ø 30 mm, and Ø 36 mm .
- . Pantheon Salvage Stem (Cemented) made of Ti6Al4V Alloy
- Size range O
- L115 Ø 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22 mm .
- Size range O
- Pantheon Salvage Stem (Uncemented) made of Ti6A14V alloy .
- Size range o
- L115 の 12, 13, 14, 15, 16, 19, 20, 22, 24 mm .
- Size range o
- . Pantheon Proximal Body Locking Screw made of Ti6A14V Alloy
- Size range o
- L50 mm, L70 mm .
- Size range o
- Pantheon Salvage Plate Compression Screws made of Ti6Al4V Alloy ●
- Size range o
- Extra-Short, Short, Medium, Long .
- Size range o
- Pantheon Salvage Plate with Spikes made of Ti6A14V Alloy .
- o Size range
- . L50 mm. L70 mm
- o Size range
- Fixa Ti-Por Cup Acetabular Shells made of Ti6Al4V Alloy additively manufactured .
- o System compatibility
7
- Cross-Linked PE Inserts l
- . Lateral Holes Plug
- . Titanium Acetabular Screw
- Size range o
- . Size 48, 50, 52, 54, 56, 58, 60, 62, 64
- Titanium Acetabular Screws made of Ti6A14V Alloy .
- o Size range
- . Diam. 6.5 mm from L15 to L50 mm in 5mm increments
- o Size range
- Acetabular Inserts Flat made of Cross-Linked PE .
- Size range o
- Internal Diam. 22, 28, 32, 36 mm .
- Size range o
- Acetabular Inserts 15° Lipped made of Cross-Linked PE .
- Size range o
- . Internal Diam. 28, 32, 36 mm
- Size range o
Summary of Technological Characteristics:
The Pantheon PFR System is substantially equivalent to the following component system 510(k)s. The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The geometries and range of available sizes are also similar. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods.
- Replacement: Stryker Orthopaedics Global Modular Pantheon Proximal Femur Replacement System (GMRS®) Proximal Femoral, K023087 (Primary Predicate)
- Pantheon Proximal Femur Replacement: Stryker Orthopaedics Global Modular ● Replacement System (GMRS®) Proximal Femoral, K040749
- CoCrMo Femoral Heads: DePuy Orthopaedics M-SPEC Metal Femoral Heads, K980513 ●
- Biolox Delta Femoral Heads: Zimmer GmbH Biolox Delta Ceramic Femoral Heads, ● K071535
- Acetabular Cups: Limacorporate S.p.A Delta TT Acetabular System, K112898 ●
- Acetabular Insert: DePuy Orthopaedics Pinnacle Altrx Polyethylene Acetabular Liner, ● K072963
- Zimmer® Segmental System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Femoral Component, and additional Segment with Male/Female Taper components, K110940
Performance Testing:
The following performance testing was performed on the Pantheon Proximal Femur Reconstruction (PFR) System:
- Neck Fatigue Testing (ISO 7206-6) ●
- Distal Stem Fatigue Testing (ISO 7206-4:2010)
- Corrosion Testing (ASTM F1875-98) ●
8
- Post Fatigue Modular Disassembly Testing (ASTM F2009-20, ISO 7206-10:2018) ●
- Taper Disassembly Testing (ASTM F2009-20, ISO 7206-10:2018) ●
- . Axial disassembly between shafts
- Torsional disassembly between shafts .
- Torsional disassembly between shaft and proximal body .
- Range of Motion (EN ISO 21535:2017) .
- Impingement Testing (ASTM F2582-20) ●
- Ceramic Head Burst Testing (ISO 7206-10, ASTM F2345) ●
- . Ceramic Head Fatigue Testing (ISO 7206-10, ASTM F2345)
- Ceramic Head Post-Fatigue Burst Testing (ISO 7206-10, ASTM F2345) ●
- Ceramic Head Disassembly (Pull-Off) Testing (ISO 7206-10, ASTM F2009) ●
- Ceramic Head Rotational Stability (Torque) Testing (ISO 7206-13) ●
- CoCrMo Head Disassembly (Pull-Off) Testing (ASTM F2009-20)
- CoCrMo Head Rotational Stability (Torque) Testing (ISO 7206-13:2016, ISO 7206-10:2018)
- Acetabular Cup Fatigue Testing (ASTM F3090-20) ●
- Insert push-out Testing (ASTM F1820-13)
- . Insert lever out Testing (ASTM F1820-13)
- Insert torque-out Testing (ASTM F1820-13)
- Insert Wear Testing (ISO 14242-1:2014/Amd1:2018, ISO 14242-2:2016)
- Acetabular Screw Torsion (ASTM F543) ●
- Acetabular Screw Driving Torque (ASTM F543) ●
- Acetabular Screw Pull-Out (ASTM F543) ●
- Acetabular Cup Deformation Testing rationale ●
Substantial Equivalence:
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The geometries and range of available sizes are also similar. The subject and predicate devices are packaged and sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.