FDA 510(k) Submissions
Organize the regulatory story and technical evidence for a well-supported submission.
- Submission planning and content support
- Predicate and substantial-equivalence research
- Review of testing and supporting documentation
Orthopedic regulatory consulting
Move orthopedic innovation forward with confidence.
Practical regulatory guidance and technical support for orthopedic medical device companies—from early development through testing, verification, and FDA submission.
✓ Orthopedic-device focus✓ Technical, evidence-based support
Regulatory clarity. Technical rigor.Specialized support for complex orthopedic devices.
Regulatory strategyPlan a clear path toward market access
Testing & verificationBuild relevant, defensible technical evidence
Orthopedic specializationSupport tailored to your device and needs
How we can help
Specialized expertise for every stage of development
Focused consulting that connects regulatory requirements with engineering decisions and the evidence needed to support them.
Testing & Verification
Develop a clear rationale for testing and turn results into useful engineering evidence.
- Test strategy and protocol development
- Mechanical performance and verification
- Data review, analysis, and reporting
Regulatory Strategy
Identify key regulatory questions early and align development work with submission needs.
- Regulatory pathway assessment
- Evidence-gap and risk reviews
- FDA question and response support
Design Controls & Quality Systems
Strengthen the connection between design inputs, outputs, verification, validation, and risk management.
- Design-control documentation review
- Traceability and verification planning
- Quality-system and process support
Literature Research
Find and assess relevant published evidence to inform device decisions and regulatory submissions.
- Scientific literature searches
- Standards and comparator research
- Evidence summaries and gap analysis
Technical Documentation
Make technical information clear, organized, and aligned with the purpose it needs to serve.
- Test reports and technical summaries
- Submission-ready documentation support
- Standards and requirements mapping
Our approach
Clear thinking. Relevant evidence. Practical next steps.
Every device has its own technical and regulatory context. The goal is to focus effort on the questions that matter, document the rationale, and help teams make informed decisions.
Start a Conversation01
Understand the device and objectiveClarify intended use, development stage, current evidence, and the questions that need to be answered.
02
Define a focused planIdentify relevant requirements, evidence gaps, testing needs, and documentation priorities.
03
Build and review the evidenceSupport the technical work and documentation needed to move the project forward.
Experience that matters
Orthopedic expertise grounded in decades of industry work
Regulatory, clinical, quality, and product-development experience across orthopedic implants and devices.
FDA Regulatory Experience
J.D. Webb’s résumé reports 241 FDA 510(k)s filed as a consultant over 20 years, plus direction of 82 additional 510(k) submissions during industry employment.
Product Development Leadership
Experience includes hip, knee, shoulder, trauma, biologic, absorbable, and external-fixation products, as well as product-line and new-product development leadership.
Quality & Clinical Programs
Experience includes implementing quality systems for startup companies, supporting successful FDA audits, and conducting clinical and outcomes studies.
J.D. Webb, President
President of The OrthoMedix Group, Inc. since 2002. Previously held orthopedic research and development, regulatory affairs, clinical affairs, and product development leadership roles at Encore Medical, Intermedics Orthopedics, and Zimmer.
M.S. in Bioengineering and B.S. in Mechanical Engineering, University of Utah.
Who we help
Support that fits your team and stage
Flexible consulting for teams that need specialized orthopedic regulatory and technical expertise.
Startups & Emerging Companies
Get targeted guidance on regulatory pathways, test planning, technical documentation, and the evidence needed to advance development.
Established Manufacturers
Bring additional expertise to complex projects, submission needs, verification programs, literature research, and technical documentation workloads.
Have an orthopedic device challenge to solve?
Let's discuss your goals and where specialized support may help.
Get in touch
Tell us about your project.
Share a brief overview of your device, development stage, or regulatory or testing question. We can start by identifying the support that best fits your needs.
Email
jdwebb@orthomedix.net
Confidentiality reminder
Please do not include confidential, proprietary, patient, or other sensitive information in this initial inquiry.
jdwebb@orthomedix.net
Confidentiality reminder
Please do not include confidential, proprietary, patient, or other sensitive information in this initial inquiry.