← Product Code [QKW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QKW) · DEN220012 # Tornier Pyrocarbon Humeral Head (DEN220012) _Tornier S.A.S. · QKW · Dec 16, 2022 · Orthopedic · DENG_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QKW/DEN220012 ## Device Facts - **Applicant:** Tornier S.A.S. - **Product Code:** [QKW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QKW.md) - **Decision Date:** Dec 16, 2022 - **Decision:** DENG - **Submission Type:** Post-NSE - **Regulation:** 21 CFR 888.3695 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by: - Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) . - . Traumatic arthritis. The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain. Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only ## Device Story Implantable shoulder prosthesis; replaces articular surface of proximal humerus. Comprises pyrolytic carbon humeral head and metallic stem (cobalt-chromium-molybdenum). Fixed with or without bone cement. Used in surgical setting by orthopedic surgeons. Increases mobility/stability; relieves pain in patients with intact/reconstructable rotator cuff. Not for total shoulder arthroplasty. ## Clinical Evidence Prospective, multi-center, single-arm IDE study (G140202) with 157 subjects; compared against 169 propensity-score matched historical controls. Primary endpoint: 24-month composite success (Constant score improvement ≥17, no revision, no disassembly/fracture, no device-related SAE). Success rate: 82.7% (Pyrocarbon) vs 66.8% (Control). Secondary endpoints (Constant, ASES, SANE, VAS, ROM, strength) showed clinically meaningful improvements exceeding MCIDs. No unanticipated adverse device effects; revision rate 1.91% (Pyrocarbon) vs 5.33% (Control). ## Technological Characteristics Humeral head made of pyrolytic carbon; stem made of cobalt-chromium-molybdenum alloys. Designed for cemented or cementless fixation. Subject to mechanical fatigue strength, fretting, corrosion, static mechanical strength, modular component disassembly, and wear analysis testing. ## Regulatory Identification A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon, and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement. It is indicated for use as a replacement of deficient humeral heads disabled by non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) or traumatic arthritis, in patients with an intact or reconstructable rotator cuff and an intact or sufficient native glenoid surface, to increase mobility, stability, and relieve pain. ## Special Controls In combination with the general controls of the FD&C Act, the shoulder joint humeral (hemishoulder) ceramic head / metallic stem cemented prosthesis is subject to the following special controls: - 1. Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and include the following: - a. Evaluation of improvement of shoulder function and reduction of symptoms, including pain and function, for the indications for use; and - b. Evaluation of adverse events, including pain, unanticipated adverse device effects, subsequent surgical interventions, wear of the native bone, osteolysis, loosening and migration, and revision, including revision due to device wear, component dissociation, or device brittle fracture. - 2. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: - a. Evaluation of the mechanical function (mechanical fatigue strength including evaluation of fretting and corrosion, static mechanical strength, modular component disassembly strength, and wear analysis) and durability of the implant; and - b. Evaluation of worst-case device range of motion. - 3. All patient-contacting components of the device must be demonstrated to be biocompatible. - 4. Performance data must support the sterility and pyrogenicity of the device components intended to be sterile. - 5. Performance data must validate the reprocessing instructions for the reusable components of the device. - 6. Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf-life. - 7. Labeling must include the following: - a. Validated methods and instructions for reprocessing of any reusable components; and - b. A shelf-life. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a De Novo](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## DE NOVO CLASSIFICATION REQUEST FOR TORNIER PYROCARBON HUMERAL HEAD #### REGULATORY INFORMATION FDA identifies this generic type of device as: Shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis. A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon, and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty. NEW REGULATION NUMBER: 888.3695 CLASSIFICATION: Class II PRODUCT CODE: OKW #### BACKGROUND DEVICE NAME: Tornier Pyrocarbon Humeral Head SUBMISSION NUMBER: DEN220012 DATE DE NOVO RECEIVED: February 8, 2022 #### SPONSOR INFORMATION: Tornier SAS % Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, Minnesota 55437 #### INDICATIONS FOR USE The Tornier Pyrocarbon Humeral Head is indicated as follows: The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by: - Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) . - . Traumatic arthritis. {1}------------------------------------------------ The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain. Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only #### LIMITATIONS The sale, distribution, and use of the Tornier Pyrocarbon Humeral Head are restricted to prescription use in accordance with 21 CFR 801.109. PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. #### DEVICE DESCRIPTION #### Implant Description The Tornier Pyrocarbon Humeral Head (Figure 1) is a prescription use device that is comprised of the pyrolytic carbon (pyrocarbon) articulating surface and a cobalt chromium alloy double taper neck. The humeral head is provided pre-assembled to the double taper to the end user and is compacted onto 510(k) cleared compatible humeral stems (K151293) for replacement of deficient humeral heads disabled by noninflammatory arthritis, or traumatic arthritis. The pyrocarbon articulating surface is made of a graphite substrate core, coated with a layer of pyrolytic carbon deposited onto the substrate via chemical vapor deposition. The pvrocarbon articulating surface is pressed into the cobalt chromium alloy double taper neck during the manufacturing process, is provided as a singular construct to the end user, and is not intended to be disassembled by the end user. Compatible monoblock humeral stems are available in titanium plasma spray coated or uncoated versions. The humeral stems are designed with a female taper connection to accept the mating male taper connection of the pyrocarbon humeral heads. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a shoulder joint replacement. On the left is the humeral head component, which is a metal ball that replaces the head of the humerus. In the middle is the scapula, which is the bone that forms the shoulder blade. On the right is the glenoid component, which is a plastic socket that replaces the glenoid fossa of the scapula. Figure 1: Tornier Pyrocarbon Humeral Head, with the pyrocarbon articulating surface pre-assembled onto the cobalt chromium alloy double taper neck alone (left), and with the Tornier Flex Shoulder humeral stem in a hemi-shoulder arthroplasty configuration (right) #### Instrument Description The Tornier Pyrocarbon Humeral Head and compatible humeral stems are implanted using Class I surgical instruments regulated under 21 CFR 888.4540, product code LXH: trials regulated under 21 CFR 888.4800, product code HWT; class II instruments previously cleared with the compatible humeral stems (K151293); and the following device specific instrumentation specific to facilitate implantation of the Tornier Pyrocarbon Humeral Head: - . Spring impactor, impactor tip supports, and pyrocarbon head impactor tip: Reusable instruments designed to deliver an appropriate amount of energy to impact the Tornier Pyrocarbon Humeral Head onto the humeral stem without damaging the pyrolytic carbon articulating surface. - Manual planar reamers and reamer tip: Reusable instruments provided for . reaming the humeral cut surface following stem implantation to ensure the bone cut is perfectly aligned so as to not interfere with seating of the Tornier Pyrocarbon Humeral Head. ### SUMMARY OF NONCLINICAL/BENCH STUDIES #### BIOCOMPATIBILITY/MATERIALS The Tornier Pyrocarbon Humeral Head is manufactured from the following patient contacting materials: Table 2: Manufactured Materials of Patient-Contacting Device Components {3}------------------------------------------------ | Description | Material | Direct
Patient
Contact | Contact Duration | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------| | Articulating
Surface | Pyrocarbon | Yes | Permanent (>30 d) | | Double
Taper | Cobalt Chromium Alloy per
ISO 5832-7 (Implants for
surgery — Metallic materials —
Part 7: Forgeable and cold-
formed cobalt-chromium-
nickel-molybdenum-iron alloy) | Yes | Permanent (>30 d) | | Patient-
contacting
Instruments | Medical Grade Stainless Steel,
Polypropylene, and Silicone | Yes | Limited (≤24 h) | Biocompatibility evaluation has been completed according to 2020 FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." For the permanent implant, the Table 3 shows the biocompatibility testing performed and the results, which were acceptable for a permanent implant in contact with bone/tissue: | Test Description | Result | |-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Cytotoxicity (per ISO 10993-5 (Biological
evaluation of medical devices — Part 5:
Tests for in vitro cytotoxicity)) | Non-cytotoxic | | Irritation (per ISO 10993-10 (Biological
evaluation of medical devices — Part 10:
Tests for irritation and skin sensitization)) | Non-Irritant | | Sensitization (per ISO 10993-10
(Biological evaluation of medical devices
— Part 10: Tests for irritation and skin
sensitization)) | Non-Sensitizing | | Implantation Effects (per ISO 10993-6
(Biological evaluation of medical devices
— Part 6: Tests for local effects after
implantation)) | Null to Minimal Reactivity | | Material Mediated Pyrogenicity (per ISO
10993-11 (Biological evaluation of
medical devices — Part 11: Tests for
systemic toxicity)) | Non-Pyrogenic | Table 3: Implant Biocompatibility Testing Performed {4}------------------------------------------------ | Acute/Subacute/Subchronic/Chronic
Systemic Toxicity, Genotoxicity and
Carcinogenicity (addressed through
chemical characterization and
toxicological risk assessment per ISO
10993-18 (Biological evaluation of
medical devices — Part 18: Chemical
characterization of medical device
materials within a risk management
process)/ISO 10993-17 (Biological
evaluation of medical devices — Part 17:
Establishment of allowable limits for | Non-systemically
toxic/genotoxic/carcinogenic | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| For the reusable silicone instruments, the Table 4 shows the biocompatibility testing performed and the results, which were acceptable for instruments in limited contact with bone/tissue: | Test Description | Result | |----------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Cytotoxicity (per ISO 10993-5 (Biological
evaluation of medical devices — Part 5:
Tests for in vitro cytotoxicity)) | Non-cytotoxic | | Irritation (per ISO 10993-10 (Biological
evaluation of medical devices — Part 10:
Tests for irritation and skin sensitization)) | Non-Irritant | | Sensitization (ISO 10993-10 (Biological
evaluation of medical devices — Part 10:
Tests for irritation and skin sensitization)) | Non-Sensitizing | | Acute Systemic Toxicity (per ISO 10993-
11 (Biological evaluation of medical
devices — Part 11: Tests for systemic
toxicity)) | Non-Toxic | Table 4: Silicone Instrument Biocompatibility Testing Performed In addition to the biocompatibility testing of silicone instruments, reference to a master file was provided to support the Material Mediated Pyrogenicity Endpoint to demonstrate the instrument is non-pyrogenic. For the reusable stainless steel and polypropylene instruments, a manufacturing rationale was provided to demonstrate acceptable biocompatibility for instruments in limited contact with bone/tissue. # STERILITY / PACKAGING AND SHELF-LIFE / PYROGENICITY Sterility: {5}------------------------------------------------ The Tornier Pyrocarbon Humeral Head is a single-use device provided clean and sterile to the end user. Gamma Sterilization of the device has been validated to provide a Sterility Assurance Level (SAL) of 10-6 based on the VDmax-5 method as recommended by FDA Recognized Consensus Standard series ANSI/AAMI/ISO 11137-1 (Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)/-2 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose). #### Packaging and Shelf-Life: The sterile barrier system consists of a double blister package sealed with Tyvek lids which is placed into a protective cardboard box. Sterilized samples accelerated aged to 5 years were used to determine the sterile shelf-life of the device. The mechanical performance of the device is not expected to degrade over time. Distribution testing (ASTM D4169 (Standard practice for performance testing of shipping containers and systems)), package integrity testing (bubble leak test. ASTM F2096 (Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test))), and seal strength testing (ASTM F88/F88M (Standard test method for seal strength of flexible barrier materials)) were used to validate the sterile shelf-life of the device. Nonclinical performance testing of the implant was used to assess the shelf-life of the device. The testing confirmed a 5 year shelf-life. ### Pyrogenicity: Bacterial endotoxins testing (BET) was performed to determine whether the Tornier Pyrocarbon Humeral Head met pyrogen limit specifications. All tested devices passed with a reported value of <1 EU/device. meeting the recommended endotoxin limits per ANSI/AAMI ST72:2011 ("Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing"). ### Reprocessing: Certain instruments for use with the Tornier Pyrocarbon Humeral Head are provided nonsterile and are to be cleaned and sterilized by the end user. Validated reprocessing instructions are included in their own separate labeling document. Steam sterilization method was validated per ISO 17665 Half Cycle Method (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) and AAMI ST79 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities) to ensure that a minimum SAL of 106 is achieved. Instruments are to be sterilized using a pre-vacuum steam autoclave. For the pre-vacuum steam autoclave cycle, the validated parameters call for an exposure time of 4 minutes at 270°F (132°C) and a dry time of 20 minutes at 270°F (132°C). Users are advised to use an FDA- cleared sterilization wrap. {6}------------------------------------------------ # MAGNETIC RESONANCE (MR) COMPATIBILITY The Tornier Pyrocarbon Humeral Head was not evaluated for safety and compatibility in a Magnetic Resonance Environment. ## PERFORMANCE TESTING - BENCH A summary of non-clinical mechanical performance evaluations is provided in Table 5: | Test | Purpose | Method | Performance
Criteria | Results | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Construct fatigue
endurance | The aim of this test is to
assess the risk of
component loosening
and potential damage
following fatigue for
the worst-case devices
and test parameters. | 5 million cycles of
compressive load
was applied in a
worst-case
orientation. | The implants were
required to survive
5 million cycles to
the pre-specified
test parameters
without
any cracks,
breakage, damage,
or dissociation. | All tested implants
survived 5 million
cycles without any
cracks, breakage,
damage, or
dissociation from
the stem. | | Taper disassembly
resistance - axial pull-
off | The aim of this test is to
assess the disassembly
resistance of the
humeral head sub-
components and of the
humeral head from the
humeral stem to axial
pull-off in the worst-
case configuration. | The test method
follows
recommendations
described in ASTM
F2009 (Standard
test method for
determining the
axial disassembly
force of taper
connections of
modular
prostheses). | No pre-determined
acceptance criteria
were defined.
Disassembly results
were compared to
another humeral
head with the same
intended use. | The minimum pull-
off load for the
Tornier Pyrocarbon
Humeral Head
exceeded the pull
off load of another
humeral head. | | Taper disassembly
resistance - torque off | The aim of this test is to
assess the disassembly
resistance of the
humeral head sub-
components and of the
humeral head from the
humeral stem to torque-
off in the worst-case
configuration. | Test methods were
adapted for shoulder
prostheses from
methods described
in ISO 7206-13
(Implants for
surgery - Partial and
total hip joint
prostheses - Part 13:
Determination of
resistance to torque
of head fixation of
stemmed femoral
components). | The torsional
resistance force
between the
Pyrocarbon
articulating surface
and the CoCr
double taper neck
must exceed
anticipated
clinically relevant
loading conditions
including an
appropriate factor of
safety. | All samples met the
pre-determined
acceptance criteria
for torsional
resistance. | | Taper disassembly
resistance - lever-off | The aim of this test is to
assess the disassembly
resistance of the
humeral head sub-
components and of the | A static lever-off
load was applied at
a constant rate until
dissociation or | No pre-determined
acceptance criteria
were defined.
Disassembly results
were compared to | The minimum lever-
off load for the
Tornier Pyrocarbon
Humeral Head
exceeded the lever-off load of another humeral head. | | Test | Purpose | Method | Performance
Criteria | Results | | | humeral head from the
humeral stem to lever-
off in the worst-case
configuration. | breakage of the
components. | another humeral
head with the same
intended use. | off load of another
humeral head. | | Fretting and corrosion
resistance | The aim of this test is to
evaluate the fretting and
corrosion resistance of
the humeral prostheses
for worst-case
compatible
components. | 5 million cycles of
compressive load
were applied in a
worst-case
orientation in a
physiologic
environment. | No pre-determined
acceptance criteria
were defined.
Visual scoring, ion
release analysis, and
particulate analysis
results were
compared to another
humeral head with
the same intended
use. | Qualitative damage
determined by
visual scoring, ion
release analysis, and
particulate analysis
demonstrated
comparable
performance to
another humeral
head with the same
intended use. | | Humeral head burst
testing (static
compression) | The aim of this test is to
evaluate the maximum
compressive load that
the humeral head may
experience prior to
breakage when
considering worst-case
components. | Static compressive
load to failure
testing was adapted
to evaluate shoulder
components from
methods described
in ISO 7206-10
(Implants for
surgery - Partial and
total hip-joint
prostheses - Part 10:
Determination of
resistance to static
load of modular
femoral heads). | A safety factor was
derived from FDA
guidance document:
"Guidance
Document for the
Preparation of
Premarket
Notification for
Ceramic Ball Hip
System," and the
fatigue load
requirements for
femoral stems from
ISO 7206-4
(Implants for
surgery - Partial
and total hip joint
prostheses - Part
4: Determination of
endurance
properties and
performance of
stemmed femoral
components). This
safety factor was
applied to the mean
fatigue load to
determine a
minimum
acceptance criteria
for burst. | All samples met the
pre-determined
acceptance criteria. | | Humeral head
subcritical crack
propagation | The aim of this test is to
evaluate the risk of
delayed component
fracture of the humeral
head for worst-case
components | Incremental load
release testing was
adapted to evaluate
shoulder implants
from methods
described in ISO | A safety factor was
derived from FDA
guidance document:
"Guidance
Document for the
Preparation of | All samples met the
pre-determined
acceptance criteria. | | Test | Purpose | Method | Performance
Criteria | Results | | | orientation due to
subcritical crack
growth. | 11491 (Implants for
surgery –
Determination of
impact resistance of
ceramic femoral
heads for hip joint
prostheses). | Premarket
Notification for
Ceramic Ball Hip
System,” and the
fatigue load
requirements for
femoral stems from
ISO 7206-4
(Implants for
surgery – Partial
and total hip joint
prostheses – Part
4: Determination of
endurance
properties and
performance of
stemmed femoral
components). This
safety factor was
applied to the mean
fatigue load to
determine a
minimum
acceptance criteria
for burst. | | | Third body wear | The aim of this test is to
evaluate the articular
wear of the humeral
head in an abrasive
condition to debris
circulating within the
joint. | Abrasive wear
conditions were
simulated on the
bench referencing
literature, ASTM
F2028 (Standard
test methods for
Dynamic Evaluation
of Glenoid
Loosening or
Disassociation, and
ISO 14242
(Implants for
surgery – Wear of
total hip-joint
prostheses). | No pre-determined
acceptance criteria
were defined.
Abrasive wear
results were
compared to another
humeral head with
the same intended
use. | Tornier Pyrocarbon
Humeral Head
demonstrated lesser
surface roughening
when exposed to an
abrasive condition
compared to another
humeral head with
the same intended
use. Wear
particulate analysis
demonstrated wear
particulates were
consistent with wear
particulates from
other arthroplasty
devices. | | Range of motion
(ROM) | The aim of this test is to
characterize the ROM
of the humeral
prosthesis for worst-
case components. | Smallest and largest
components were
evaluated when
paired with virtual
scapula models to
determine the ROM
of the system prior
to implantation in
accordance with
ASTM F1378
(Standard | Performance criteria
were defined from
ASTM F1378
(Standard
specification for
shoulder
prostheses):
Flexion shall be
equal to or greater
than 90°. Extension
shall be equal to or | All simulated
constructs met the
pre-determined
acceptance criteria. | | Test | Purpose | Method | Performance
Criteria | Results | | | | specification for
shoulder
prostheses). | greater than 45°.
Abduction shall be
equal to or greater
than 90°. Internal
Rotation shall be
equal to or greater
than 90°. External
rotation shall be
equal to or greater
than 45°. | | | Spring impactor testing | The aim of this test is to
assess the function of
the impactor instrument
in response to both
fatigue testing and
extended cycles of
cleaning and
sterilization. | The spring impactor
was cycled through
extended simulated
use, cleaning, and
sterilization cycles. | The performance of
the instrument (e.g.,
spring stiffness and
ability to impact the
humeral head onto
the stem) should not
be impacted from
repeated use,
cleaning, or
sterilization. | The spring
impactor's
performance was
not impacted from
extended cycles of
simulated use,
cleaning, or
sterilization of the
device. | Table 5: Summary of Non-clinical Mechanical Performance Evaluations {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## SUMMARY OF CLINICAL INFORMATION ### Study Design The sponsor conducted a prospective, multi-center, single-arm investigational study under IDE G140202 - Pyrocarbon IDE Study. A total of 157 subjects were enrolled across 18 sites within the US. While the study was originally designed as a performance goal study, the study design changed to a non-inferiority historically controlled study with Propensity Score (PS) analysis at FDA's request. Control data originated from the Aequalis Post-Market Outcomes Study dataset for a 510(k) cleared cobalt chromium humeral head hemiarthroplasty device (i.e. Tornier Flex Cobalt Chromium Humeral Head). A blinded independent statistician implemented a two-stage, outcome-free PS design, and after PS matching, 169 control subjects were selected. The purpose of the study was to evaluate the safety and effectiveness of the pyrocarbon humeral head as a hemiarthroplasty for patients with non-inflammatory arthritis or post-traumatic arthritis when compared to cobalt chromium humeral heads. Subjects were followed to Month 24 posttreatment for study endpoint analysis. ### Subject Demographics A total of 157 subject were enrolled for the investigational trial. After PS matching, 169 control subjects were selected from the Aequalis Post-Market Outcomes Study dataset. The two treatment groups were similar in terms of demographics and baseline characteristics, with an overall mean age and standard deviation of 52.1 ± 10.8 years for the Pyrocarbon group, and 54.9 ± 11.4 years for the control group. The study population was 79% male for the Pyrocarbon group and 72.8% for the control group with average body mass index (BMI) of 30.4 ± 7.0, and 29.2 ± 5.9, respectively. The primary diagnosis in both treatment groups was primary glenohumeral arthritis, comprising 86.6% of patients for the Pyrocarbon group and 82.8% of the control group. {10}------------------------------------------------ Breakdown of age (beyond mean), race, and ethnicity specific data were not reported in the clinical study. Table 6 presents a summary of the baseline characteristics for the Pyrocarbon group and control groups (with and without outcome data): | Measure | Pyrocarbon | Control
(Overall) | Control
(with outcome
data) | Control
(without
outcome data) | |------------------------------------------|-------------|----------------------|-----------------------------------|--------------------------------------| | N | 157 | 169 | 73 | 96 | | Age, years | 52.1 ± 10.8 | 54.9 ± 11.4 | 55.9 ± 10.2 | 54.1 ± 12.2 | | BMI, kg/m2 | 30.4 ± 7.0 | 29.2 ± 5.9 | 29.2 ± 5.9 | 29.2 ± 5.9 | | Constant Activity Score | 7.8 ± 3.7 | 6.9 ± 3.2 | 6.8 ± 3.4 | 7.1 ± 3.3 | | Constant Pain Score | 4.9 ± 3.2 | 3.4 ± 2.2 | 3.4 ± 2.3 | 3.3 ± 2.3 | | Adjusted Constant Score | 49.1 ± 17.4 | 46.0 ± 17.5 | 47.4 ± 17.8 | 44.9 ± 17.6 | | Sex = Male, % | 79.0% | 72.8% | 78.1% | 68.8% | | Diagnosis, % | | | | | | Avascular Necrosis | 7.6% | 10.7% | 6.9% | 13.5% | | Post-traumatic Arthritis | 5.7% | 6.5% | 8.2% | 5.2% | | Primary Glenohumeral Arthritis | 86.6% | 82.8% | 84.9% | 81.3% | | Dexterity = Right, % | 86.0% | 91.1% | 90.4% | 91.7% | | Operated Shoulder = Right, % | 58.0% | 59.2% | 65.8% | 54.2% | | Hospital with Large Number of
Beds, % | 65.6% | 72.8% | 75.3% | 70.8% | | Private Institution, % | 62.4% | 79.9% | 82.2% | 78.1% | Table 6. Patient Baseline Characteristics ## Primary Endpoint The primary composite endpoint for the study was defined as the rate of patient success at 24 months. A patient was considered a success at 24 months if: - Their change in Constant score is ≥ 17; . - o They did not have revision surgery: - . There is no radiographic evidence of system disassembly or fracture; AND - . They did not have a system-related serious adverse event. For the intent to treat set, using multiple imputation to account for missing data, the success rate was 82.7% for the Pvrocarbon group, and 66.8% for the control group. The success rate of Pyrocarbon group led the control by 15.9%. For the per protocol set, after imputation, the success rate was 87.9% for the Pyrocarbon group, and 63.1% for the control group, success rate for Pyrocarbon group was 24.8% higher than for the control group. The sponsor applied a twowav generalized linear model to adjust for propensity score subclass, and used model results to support the non-inferiority claim. Results are presented in Table 7 for all study subjects. | | Pyrocarbon | | | Control | | | |------------------------------------|------------|-----|-------|---------|-----|-------| | Outcome | N | n | % | N | n | % | | Free of Revision | 157 | 154 | 98.1% | 169 | 160 | 94.7% | | Constant Score improved 17+ points | 143 | 121 | 84.6% | 67 | 49 | 73.1% | Table 7: Primary Endpoint Success at Month 24 Post-treatment {11}------------------------------------------------ | | Pyrocarbon | | | Control | | | |----------------------------------|------------|-----|--------|---------|-----|--------| | Outcome | N | n | % | N | n | % | | Free of disassembly or fracture | 157 | 157 | 100.0% | 169 | 169 | 100.0% | | Free of device related SAE | 157 | 152 | 96.8% | 169 | 160 | 94.7% | | Composite Clinical Success (CCS) | 157 | -- | 82.7% | 169 | -- | 66.8% | | CCS - Completers | 146 | 120 | 82.2% | 73 | 49 | 67.1% | | CCS - Best Case | 157 | 131 | 83.4% | 169 | 49 | 29.0% | | CCS - Worst-case | 157 | 120 | 76.4% | 169 | 145 | 85.8% | While the historical control group was missing a significant portion of outcome data, all control subjects with missing data are conservatively assumed to be a success in the primary endpoint analysis. To assess for potential selection bias, the sponsor provided an analysis of baseline characteristics for control completers comparing with control subjects with missing data. The analysis indicated that there are no significant differences in baseline demographics or comorbidity characteristics between control completers and control subjects with missing data. The performance of the control group was also compared to literature, noting that the revision rate and the mean improvement in Constant Score are consistent with published data in literature and real-world data, as presented in Table 8. | Name | Endpoint | Average Follow
Up (months) | Sample Size | Estimate | |----------------------------------------------------|-------------------------------------------|-------------------------------|-------------|-----------| | Historical Control | Revision Rate | 24 | 169 | 5.3% | | Meta Analyses of
Hemiarthroplasty
Literature | Revision Rate | 55 | 835 | 11.1% | | Australian Joint
Registry 2021 | Revision Rate | 24 | 5332 | 5.45% | | Historical Control | Constant Score
Change from
baseline | 24 | 57 | 28.6±19.9 | | Meta Analyses of
Hemiarthroplasty
Literature | Constant Score
Change from
baseline | 56 | 626 | 31.8±10.3 | | Fonte et. al. Meta
Analysis1 | Constant Score
Change from
baseline | 14-240 | 341 | 29.6 | Table 8: Control Group Performance Comparison to Literature and Real World Data In addition to the comparison of baseline characteristics between control subjects with or without complete outcome data, and the comparison of outcome data of the control subjects to literature, a tipping point analysis was conducted to analyze the sensitivity of missing data. Compared to the multiple imputation model, the tipping point analysis does not require the same statistical assumptions as it analyzes every possible combination of the missing data. Based on modeling where all possible combinations of missing data were used to assess success or failure in the 1 Fonte H, Amorim-Barbosa T, Diniz S, Barros L. Ramos J, Claro R. Shoulder Arthroplasty Options for Glenohumeral Osteoarthritis in Young and Active Patients (<60 Years Old): A Systematic Review. J Shoulder Elb Arthroplast. 2022;6:24715492221087014. Published 2022 Mar 23. doi:10.1177/24715492221087014 {12}------------------------------------------------ overall success measurement, only 68 of the 1.164 (5.8%) scenarios would change the study conclusions. The overall success criterion was met in the other 1,096 (>94%) potential missing data combinations. This indicates that the tipping point analysis, along with the multiple imputation analysis and supporting information, demonstrate that the non-inferiority result is insensitive to the presence of missing data. ## Secondary Endpoints Secondary endpoints assessed during the study included the Constant Score, Adjusted Constant Score, American Shoulder and Elbow Surgeons (ASES) Score, Single Assessment Numeric Evaluation (SANE), EQ-5D, Pain measured by a visual analog scale (VAS), ROM, and strength. The Adjusted Constant Score change of 40.5 points in 24 months, observed in the Pyrocarbon IDE study is greater than the minimally clinical important differences (MCID) determined by Holmgren et al who defined a MCID in the Adjusted Constant score for subjects treated conservatively for subacromial pain to be between 17-24 points.2 The Constant Score change of 34.3 observed in the Pyrocarbon IDE study is greater than the MCID determined by additional literature that reports the MCID in Constant Score for shoulder arthroplasty to be 5.7-9.4.3 The ASES change of 43.4 in 24 months, observed in the Pyrocarbon IDE study is greater than the MCID determined by Tashiian et al (12-17 points) for rotator cuff disease (tendonitis or tears).4 The SANE change of 49.5 points observed in the Pyrocarbon IDE study is greater than the MCID determined by Zhou et al (27.25 points) for rotator cuff repairs.6 EQ-5D change of 0.21 points observed in the Pyrocarbon IDE study is greater than the MCID determined by Hao et al (0.02-0.11) for subacromial pain.6 Pain was assessed in the study using a 10-pt (0-no pain at all. 10-pain as bad as it can be) pain VAS (taken from the pain portion of the ASES standardized score). The mean subject reported pain went from 5.5 to 1.1 on the VAS scale with a mean change of -4.2 ± 2.8. The change observed in the Pyrocarbon IDE study is greater than the MCID determined by Hao et al (-1.5) for subacromial pain. The ROM change observed in the Pyrocarbon IDE study at two years are consistent with the results observed by Sowa et al who assessed change in ROM at an average of four years after shoulder hemiarthroplasty. 7 The mean change in strength observed was 5.0±7.6 lbs. at 24 months. These results in the Pyrocarbon IDE study at 24 months are consistent with the 2 Holmgren T. Oberg B. Adolfsson L. Björnsson Hallgren H. Minimal important changes in the Constant-Murley score in patients with subacromial pain. J Shoulder Elbow Surg. 2014;23(8):1083-1090. doi:10.1016/j.jse.2014.01.014 3 Dabija DI, Jain NB. Minimal Clinically Important Difference of Shoulder Outcome Measures and Diagnoses: A Systematic Review. Am J Phys Med Rehabil. 2019;98(8):671-676. doi:10.1097/PHM.00000000001169 4 Tashian RZ. Deloach J. Green A. Porucznik CA. Powell AP. Minimal clinically important differences in ASES and simple shoulder test scores after nonoperative treatment of rotator cuff disease. J Bone Joint Surg Am. 2010:92(2):296-303. doi:10.2106/JBJS.H.01296 5 Zhou L. Nataraian M. Miller BS. Gagnier JJ. Establishing Minimal Important Differences for the VR-12 and SANE Scores in Patients Following Treatment of Rotator Cuff Tears. Orthop J Sports Med. 2018:6(7):2325967118782159. Published 2018 Jul 26. doi:10.1177/2325967118782159 6 Hao O. Devii T. Zeraatkar D. et al. Minimal important differences for improvement in shoulder condition patientreported outcomes: a systematic review to inform a BMJ Rapid Recommendation. BMJ Open. 2019:9(2):e02877. Published 2019 Feb 20. doi:10.1136/bmjopen-2018-028777 7 Sowa B. Thierjung H. Bülhoff M, et al. Functional results of hemi- and total shoulder arthroplasty according to diagnosis and patient age at surgery. Acta Orthop. 2017;88(3):310-314. doi:10.1080/17453674.2017.1280656 {13}------------------------------------------------ 12-month results observed by Sperling et al who assessed change in strength after total shoulder arthroplasty on subjects with an intact rotator cuff.8 # Safety Analysis There were no Unanticipated Adverse Device Effects as determined by the independent medical monitor. All device- and procedure-related serious adverse events (SAEs) were considered expected complications for total shoulder arthroplasty. In the IDE data, there were 3 revisions (3/157, 1.91%) and zero instances of humeral head fracture and/or disassembly at 24 months for the Pyrocarbon group. In Historical Control, SAEs reported include 9 revisions (9/169, 5.33%), which is consistent with the hemiarthroplasty revision rate (5.45%) reported in the 2021 Australian joint registry. SAEs possibly related to the device include rotator cuff tear (2/157, 1.27%). SAEs possibly related to the procedure include: arthrofibrosis, atelectasis, biceps rupture, brachial plexus palsy, deep vein thrombosis, pain, pulmonary emboli, rotator cuff tear, stroke, and infection. ## Pediatric Extrapolation In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population. ## LABELING The labeling consists of the following: device description, indications for use, instructions for use including surgical steps (e.g., device selection and placement), principles of device operation, identification of device materials, contraindications, warnings, precautions, a list of potential adverse effects, and importance of patient compliance with postoperative activity restrictions. Furthermore, the sterile packaging includes a shelf-life for the device. The labeling meets the requirements of 21 CFR 801.109 for prescription devices. ## RISKS TO HEALTH The table below identifies the risks to health that may be associated with use of the shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis and the measures necessary to mitigate these risks. | Identified Risks to Health | Mitigation Measures | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Adverse events of the index shoulder including
pain, unanticipated adverse device effects,
subsequent surgical interventions, wear of the
native bone, osteolysis, loosening and
migration, and revision, including revision due | Clinical data
Non-clinical performance testing
Biocompatibility evaluation | 8 Sperling JW. Kaufman KR. Schleck CD. Cofield RH. A biomechanical analysis of strength and motion following total shoulder arthroplasty. Int J Shoulder Surg. 2008;2(1):1-3. doi:10.4103/0973-6042.39579 {14}------------------------------------------------ | Identified Risks to Health | Mitigation Measures | |---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | to device wear, component dissociation, or
device brittle fracture | | | Adverse tissue reaction due to
• Device materials
• Fretting and corrosion
• Wear particulates | Biocompatibility evaluation
Non-clinical performance testing | | Infection | Sterilization validation
Reprocessing validation
Shelf-life testing
Pyrogenicity testing
Labeling | | Insufficient range of motion | Non-clinical performance testing | ## SPECIAL CONTROLS In combination with the general controls of the FD&C Act, the shoulder joint humeral (hemishoulder) ceramic head / metallic stem cemented prosthesis is subject to the following special controls: - 1. Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and include the following: - a. Evaluation of improvement of shoulder function and reduction of symptoms, including pain and function, for the indications for use; and - b. Evaluation of adverse events, including pain, unanticipated adverse device effects, subsequent surgical interventions, wear of the native bone, osteolysis, loosening and migration, and revision, including revision due to device wear, component dissociation, or device brittle fracture. - 2. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: - a. Evaluation of the mechanical function (mechanical fatigue strength including evaluation of fretting and corrosion, static mechanical strength, modular component disassembly strength, and wear analysis) and durability of the implant; and - b. Evaluation of worst-case device range of motion. - 3. All patient-contacting components of the device must be demonstrated to be biocompatible. - 4. Performance data must support the sterility and pyrogenicity of the device components intended to be sterile. - 5. Performance data must validate the reprocessing instructions for the reusable components of the device. - 6. Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf-life. - 7. Labeling must include the following: - a. Validated methods and instructions for reprocessing of any reusable components; and {15}------------------------------------------------ - b. A shelf-life. ## BENEFIT-RISK DETERMINATION ### BENEFITS: - 1) The clinical study demonstrates Tornier Pyrocarbon Humeral Head leads to clinically meaningful improvements in shoulder function and symptoms (e.g., reduction in pain) that are maintained over time to at least 24 months; - 2) Performance has demonstrated to be non-inferior to Cobalt Chrome Hemiarthroplasty; - 3) Literature on clinical use and in vitro testing demonstrate decreases in native glenoid wear when compared to Cobalt Chrome devices; - 4) The Tornier Pyrocarbon Humeral Head secondary endpoint results (Constant Score, ASES, SANE, VAS, Strength, and Revision Rate) support clinically meaningful, patientvalued benefits at a magnitude similar to, or numerically greater than, those observed with the Control device: AND - 5) Improvement in long-term implant survival rates and delay of TSA conversion. ## RISKS: - 1) Adverse events of the index shoulder including pain, unanticipated adverse device effects, subsequent surgical interventions, wear of the native bone, osteolysis, loosening and migration, and revision, including revision due to device wear, component dissociation, or device brittle fracture: - 2) Adverse tissue reactions due to device materials: fretting and corrosion: and wear particulates: - 3) Infection: AND - 4) Insufficient range of motion. Based on the totality of the evidence, the Tornier Pyrocarbon Humeral Head demonstrated a reasonable assurance of safety and effectiveness for the device for its intended use/indications for use and while there is a medium degree of uncertainty in this finding due to missing data from the control group in the clinical study, the risks are not greater than the current standard of care. In addition, the pyrocarbon humeral head demonstrated lower revision rates over the course of the clinical study, and literature and in vitro testing demonstrate a probable benefit of decreased glenoid wear when compared to a cobalt chrome hemiarthroplasty. In conclusion, the benefits of using the Tornier Pyrocarbon Humeral Head for its intended use/indications for use outweigh the risks to health. ### PATIENT PERSPECTIVES Patient perspectives considered for the Tornier Pyrocarbon Humeral Head during the review include: The primary composite study endpoints included assessment of improvement in pain and function using patient reported metrics (e.g., Constant score) at month 24. {16}------------------------------------------------ Additionally, pre-specified secondary effectiveness study endpoints included the following scales: Constant score, ASES, SANE, EQ5D, VAS Pain Scale, ROM, and change in strength to evaluate the treatment effect at 24 months. These patient reported outcomes (PROs) are used to demonstrate a clinically meaningful improvement in pain and function. ### BENEFIT/RISK CONCLUSION In conclusion, given the available information above, for the following indication statement: "The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by: - · Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis). - . Traumatic arthritis. The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain. Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only" The probable benefits outweigh the probable risks for the Tornier Pyrocarbon Humeral Head. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls. ### CONCLUSION The De Novo for the Tornier Pyrocarbon Humeral Head is granted and the device is classified as follows: Product Code: OKW Device Type: Shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis Regulation Number: 21 CFR 888.3695 Class: Class II --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QKW/DEN220012](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QKW/DEN220012) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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