Surgeon-Directed. Precision-Fabricated.

Instruments built for
the anatomy in front of you.

No two patients are alike. Neither should your instruments be. 1of1surgical delivers prescription-level modification of surgical instruments — designed by a surgeon, fabricated to your exact specification.

Submit a Modification Request See How It Works
20–25
Day delivery target
21 CFR
Custom device exemption
1of1
Every instrument is unique
Founded by a Board-Certified Vascular Surgeon
FDA Custom Device Exemption (21 CFR 812.3(b))
QMS-Compliant Design & Fabrication Workflow
Medical-Grade Materials — 316L & 17-4 PH Stainless
The Clinical Gap

Standard instruments are built for the average patient.
Your patients aren't average.

The Problem with Off-the-Shelf

The surgical instrument industry treats the OR as a mass market. Fixed lengths, fixed angles, fixed geometry — designed for an average patient that doesn't exist.

  • Obese patients require retractors 2–4 cm longer than standard stock
  • Reoperative fields impose spatial constraints that fixed instruments can't address
  • Non-standard approach angles are unachievable with off-the-shelf geometry
  • Surgeons improvise with the wrong tool — or modify instruments themselves, unsafely

The 1of1surgical Solution

We offer structured, physician-directed modification of existing FDA-cleared instruments — starting with your base instrument and delivering what the case actually demands.

  • Handle extensions for depth — tailored to the patient and operative field
  • Angle modifications for non-standard approach trajectories
  • Jaw geometry adjustments for improved tissue handling
  • Surface profile modifications for grip and control
  • Full documentation, QMS compliance, Device History Records
The Process

From request to sterile delivery in under 25 days.

Every modification follows a rigorous design-review and fabrication workflow. You're involved at every step that matters.

01
Intake
Submit your request — base instrument, desired modification, and clinical rationale. Direct consult available.
Day 1
02
Design Review
Surgical founder reviews the spec. Engineering drawing produced and sent back to you for approval.
Days 2–5
03
Fabrication
ISO-certified precision machining partner modifies the base instrument to your exact specification in surgical-grade stainless.
Days 5–15
04
QC & Documentation
Dimensional inspection, biocompatibility verification, Device History Record filed. Every unit traceable.
Days 15–17
05
Delivery
Instrument delivered for sterilization via your hospital central sterile or contract sterilization service.
Day 20–25
Who We Serve

Serving surgeons across the specialties where anatomy varies most.

Vascular Surgery
Deep pelvic, retroperitoneal exposures; obese patient panels; reoperative aortic cases. Founder's specialty.
General & Bariatric
Laparoscopic and open cases in morbidly obese patients requiring extended-length instruments across the operative field.
Orthopedic Surgery
Joint reconstruction, spine, and trauma — anatomy variability across joints drives deep customization needs.
Neurosurgery
Cranial and spinal approaches where millimeter-level instrument geometry directly affects safety margins.
Urological Surgery
Robotic-assisted and open pelvic procedures requiring precision reach and angle in confined anatomical spaces.
Colorectal Surgery
Pelvic dissection in narrow male pelves, low anterior resections requiring non-standard geometric access.
Thoracic Surgery
Instrumentation depth in large chest cavities and hybrid procedures with variable triangulation constraints.
Gynecologic Oncology
Radical pelvic surgery with variable anatomy — a niche but highly engaged surgical community.
Physician-Founded

Built by a surgeon who lived this problem every day.

RK
Rahul Kar, MD, RPVI
Founder & CEO
Board-Certified Vascular Surgeon
Registered Physician in Vascular Interpretation (RPVI)
Private Practice, Columbus, OH
1of1surgical Founder & Chief Medical Officer

Credibility no engineering firm can replicate.

1of1surgical was founded by Rahul Kar, MD, RPVI — a board-certified vascular surgeon in active private practice in Columbus, Ohio. The company was not built from a business school case study. It was built from the operating room.

As a vascular surgeon, Dr. Kar routinely encounters the structural mismatch between what surgical instrument manufacturers offer and what complex anatomy actually demands: retroperitoneal exposures in morbidly obese patients, reoperative aortic cases with dense adhesions, pelvic dissections with non-standard approach trajectories. The current workaround — improvising with the wrong instrument, or modifying instruments in an uncontrolled fashion — is not safe, reproducible, or defensible.

"No two patients are the same. It is time our instruments reflected that. 1of1surgical exists because the alternative — a surgeon improvising with the wrong tool — is not good enough."

1of1surgical is structured around the founder's surgical credibility as its primary competitive advantage. Every modification request is reviewed by a surgeon who has held the instruments, operated in the same anatomical spaces, and understands what the engineering drawing needs to achieve.

Regulatory Framework

Compliant from day one. Built to scale.

1of1surgical operates under a documented regulatory strategy appropriate to each phase of growth — beginning with the FDA's Custom Device Exemption and building toward 510(k) clearance as volume demands.

Phase 1 · Current
Custom Device Exemption
Operating under 21 CFR 812.3(b), which permits manufacture of devices ordered by a licensed practitioner for individual patient use. Device History Records maintained for every unit. Per-configuration volume tracking enforces compliance.
Active
Phase 2 · Year 2
510(k) Clearance
As volume and modification frequency scale beyond CDE thresholds, 1of1surgical will pursue 510(k) clearance for its highest-volume modification categories — treating them as modified predicates with established safety profiles.
In Planning
Phase 3 · Year 3–5
Catalog Product Line
Popular, validated modifications offered as a cleared small-run catalog — moving from bespoke service to repeatable, scalable product lines in vascular, orthopedic, and general surgery.
Future
Work With Us

Request a modification consult.

Tell us about the instrument, the anatomy, and the clinical challenge. We'll review it and respond within one business day.

rahul001kar@gmail.com
(909) 809-6714
Columbus, Ohio

All submissions are treated as confidential. We respond within one business day.