BETA
Manufacturer of the Ocelot handheld system for mechanical fragmentation and debridement of soft tissue in minimally invasive procedures.
TendoNova is an Atlanta, Georgia medical-device company founded in 2017. It develops and manufactures the Ocelot system for office-based and ambulatory procedures involving chronic tendon disorders. Ocelot combines a rechargeable drive unit, charging cradle and sterile disposable cutting assembly.
The company currently markets the platform as Ocelot Nano; its FDA decision and submitted labeling use Ocelot TDS 1000. The cutting mechanism is mechanical oscillation, with ultrasound imaging used separately for procedural guidance. FDA clearance covers fragmentation or debridement of soft tissue.
Current executive leadership identifies Chas Harris as CEO and Brett Rogers as COO. The company advertises independent U.S. distributor opportunities. Upright Medical Solutions advertises Ocelot, while a dated 2023 manufacturer announcement documents a separate agreement with AcCELLerated Biologics.
FDA cleared Ocelot TDS 1000 under K212049 on March 8, 2022 for fragmentation or debridement of soft tissue. The summary describes mechanical oscillation and separate ultrasound guidance. This is a 510(k) clearance, not PMA approval; FDA lists the device as unclassified under product code LFL. [15][11]
One relevant clearance maps to the current Ocelot family. Unrelated Avinger Ocelot catheters and DePuy Ocelot cages are excluded. The manufacturer discusses adjunctive biologic delivery, but that does not establish authorization of a biologic product or a combined-treatment claim. [11][5]
Published FDA searches under the company and selected product names found no relevant original PMA approvals, De Novo grants or recall events. Unrelated name matches are excluded. [14][12][13][16]
Latest recorded source review: 2026-10-27.
Documented commercial product families.
Battery-powered reusable drive unit with sterile disposable cutter, charging cradle and optional operating-data application. The cutter oscillates mechanically; ultrasound imaging provides separate guidance. [5][11][15]
FDA-clearedCommercially marketed in the United States to office-based clinicians and ambulatory surgery centers.
TendoNova advertises independent distributor recruitment in selected U.S. territories, including Ohio. Such advertisements indicate network-development activity, not established appointments or employee headcount. A separate March 2023 announcement documents an agreement with AcCELLerated Biologics; current contractual status is not independently confirmed. [17][2]
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Upright Medical Solutions (distributor-reported) [10] | U.S. provider-facing offering; product-specific territory and active contract not independently confirmed | Ocelot percutaneous tenotomy system |
| AcCELLerated Biologics (agreement announced 2023) [2] | Not specified; current contractual status unconfirmed | Ocelot system |
Sources checked October 26, 2026.
FDA issued a substantial-equivalence decision for Ocelot TDS 1000. [15]
Accessed 10/27/2026
Last substantive review: 10/27/2026