[Malvern, PA] — September 17, 2026 — Pace Surgical today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the Tempo™ Variable Locking Plating System, a comprehensive internal fixation platform.
Pace Surgical Receives FDA 510(k) Clearance for the Tempo™ Variable Locking Plating System
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traumafoot and ankle510(k) clearancePace SurgicalTempo™ Variable Locking Plating System
The Tempo system combines an anatomically contoured plate family with variable-angle locking technology, allowing surgeons to select screw trajectory intraoperatively while preserving the construct stability of a fixed-angle design. The platform comprises plate configurations and a screw portfolio delivered in a streamlined instrument set built to reduce tray count and simplify reprocessing for hospital and ASC customers.
“Tempo is the next step in bringing our comprehensive fixation platform to market. The pre-contoured plates paired with the variable locking technology gives surgeons the right implant for the right indication. Designed by leading foot and ankle, and trauma surgeons, this platform is built for patients, by their surgeons. “ — Jeff O’Donnell Jr., CEO, Pace Surgical
Pace will exhibit the cleared Tempo system at the 2026 AOFAS Annual Meeting and IFFAS 9th Biennial Meeting, September 16–19 in Seattle, Washington, at booth 1243.
Pace Surgical is planning an alpha launch of the Tempo™ Variable Locking Plating System in early 2027.
“Pace’s Tempo VLP System is an impressive combination of anatomical precision and versatility. The plate profiles and contours allow for a more anatomical fit and reconstruction, while the scope of the portfolio gives surgeons the right solution for virtually every foot and ankle case. I am excited to use this all in one streamline system.” — Lew Schon, M.D.
Surgeons, distributors, and prospective partners attending AOFAS are invited to visit booth 1243 or to arrange a meeting in advance at info@runwayhc.com. Pace Surgical operates within Runway Healthcare, a MedTech venture studio that develops and scales breakthrough technologies in Orthopedics, Trauma, and Spine through a focused, capital-efficient model.
The Tempo Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra- and extra-articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion, and reconstruction of small bones of the toes, feet, and ankles, including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in adult patients. The plates are indicated for use in bones of the feet, including the toes, midfoot, and hindfoot. In addition, the non-locking screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
Forward-Looking Statements:
This press release contains "forward-looking statements" concerning the development of Pace Surgical products, the potential benefits and attributes of those products, and the company's expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions, and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Pace Surgical undertakes no obligation to update any forward-looking statements for any reason.
About Pace Surgical:
Pace Surgical was founded to provide foot and ankle surgeons with solutions that preserve anatomical constructs and increase the quality of life for patients. Pace Surgical's majority stockholder is Runway Healthcare, LP, a MedTech accelerator investment fund. Visit Pace-Surgical.com.
About Runway Healthcare:
Runway Healthcare is an early-stage medical device Venture Studio focused on early-stage technology in the Orthopedic, Cardiovascular, and Neurology sectors. Runway Healthcare finances and manages the product development process of its portfolio companies. Upon navigating a portfolio company through the regulatory process, Runway Healthcare will seek to transition the company's ownership to larger multi-national healthcare companies for commercialization. Visit https://runwayhc.com.
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TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Pace Surgical secured FDA 510(k) clearance for its Tempo™ Variable Locking Plating System, a strategic move to enter the foot and ankle internal fixation market. This comprehensive platform, developed under MedTech venture studio Runway Healthcare, targets hospitals and ASCs with a streamlined instrument set. An alpha launch is planned for early 2027, positioning Pace Surgical to compete in the trauma and reconstruction segments.
- The system aims to reduce tray count and simplify reprocessing, offering cost efficiencies for healthcare providers.
- Pace Surgical's strategy involves a focused alpha launch in early 2027, leveraging its parent company Runway Healthcare's model for market entry.
PhD Lens: Clinical and outcomes impact
Pace Surgical's Tempo™ Variable Locking Plating System received 510(k) clearance, offering an internal fixation platform with anatomically contoured plates and variable-angle locking technology. This design allows surgeons to adjust screw trajectory intraoperatively while maintaining fixed-angle construct stability. It is indicated for stabilization and fixation of various fractures, osteotomies, fusions, and reconstructions of small bones in adult patients.
- The system combines pre-contoured plates with variable locking technology, enabling customized screw placement for diverse anatomical indications.
- Indications include intra- and extra-articular fractures, joint depression, multi-fragmentary fractures, revision procedures, and joint fusion in the foot, ankle, hand, and wrist.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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