After more than four decades contributing to hundreds of successful regulatory approvals for most orthopaedic implant manufacturers, Orthopaedic Research Laboratories, Inc. (ORL) is concluding its operations. ORL’s physical and computational testing capabilities and development consulting services have transitioned to Section 7 Testing, LLC (S7T). S7T is led by Ed Morra, MSME, a 30-year member of the ORL team.
Services
Section 7 Testing has over 30 years of experience generating reports that sail through regulatory agencies such as the USFDA. Standards testing, custom testing, and advanced computational product development are our specialties.
Standards
ISO
7206
8827
11491
14242
14879
15142
18192
22622
23089
ASTM
F382
F384
F543
F564
F1223
F1264
F1357
F1378
F1541
F1714
F1717
F1781
F1798
F1800
F1814
F1820
F1829
F1875
F2009
F2028
F2077
F2180
F2193
F2267
F2345
F2346
F2423
F2502
F2580
F2582
F2624
F2665
F2706
F2723
F2724
F2777
F2979
F3090
F3129
F3140
F3143
F3210
F3295
F3437
F3446
F3495
F3574
F3631
F3690
F3738
Custom
Regulatory deficiency letters
Small joints
Fixation
Computational
All virtual tests accepted by USFDA, many predicates
F1223
F2996
F3161
F3334
KneeSIM range of motion
Contact area and stress
Anatomy Bundles
Most clients need a battery of tests to clear a single implant. S7T offers bundle pricing on combined mechanical, wear, and computational programs by anatomy.
ISO 14879 Total knee-joint prostheses: endurance properties of knee tibial trays
ASTM F1223 Determination of Total Knee Replacement Constraint
ASTM F1800 Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
ASTM F1814 Evaluating Modular Hip and Knee Joint Components
ASTM F2723 Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
ASTM F2724 Evaluating Mobile Bearing Knee Dislocation
ASTM F2777 Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
ASTM F3140 Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
ASTM F3161 Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
ASTM F3210 Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
ASTM F3334 Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
ASTM F3495 Determining the Static Failure Load of Ceramic Knee Femoral Components
ISO 7206 Partial and total hip joint prostheses
ISO 11491 Determination of impact resistance of ceramic femoral heads for hip joint prostheses
ISO 14242 Wear of total hip-joint prostheses
ASTM F1714 Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
ASTM F1814 Evaluating Modular Hip and Knee Joint Components
ASTM F1820 Determining the Forces for Disassembly of Modular Acetabular Devices
ASTM F1875 Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
ASTM F2009 Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
ASTM F2345 Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
ASTM F2580 Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses
ASTM F2582 Dynamic Impingement Between Femoral and Acetabular Hip Components
ASTM F2979 Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
ASTM F2996 Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
ASTM F3090 Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements
ASTM F3129 Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
ASTM F3143 Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
ASTM F3446 Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
ASTM F3738 Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles
ISO 18192 Wear of total intervertebral spinal disc prostheses
ISO 23089 Preclinical mechanical assessment of spinal intervertebral body fusion devices
ASTM F1717 Spinal Implant Constructs in a Vertebrectomy Model
ASTM F1798 Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F2077 Intervertebral Body Fusion Devices
ASTM F2193 Components Used in the Surgical Fixation of the Spinal Skeletal System
ASTM F2267 Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
ASTM F2346 Static and Dynamic Characterization of Spinal Artificial Discs
ASTM F2423 Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
ASTM F2624 Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
ASTM F2706 Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
ASTM F3295 Impingement Testing of Total Disc Prostheses
ASTM F3574 Sacroiliac Joint Fusion Devices
ASTM F3631 Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
ASTM F1378 Shoulder Prostheses
ASTM F1829 Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
ASTM F2028 Dynamic Evaluation of Glenoid Loosening
ISO 22622 Wear of total ankle-joint prostheses
ASTM F2665 Total Ankle Replacement Prosthesis
ISO 8827 Staples with parallel legs for orthopaedic use