Carlsmed, Inc. filed Carlsmed, Inc. v. DeGen Medical, Inc., No. 4:26-cv-04064 (D.S.C. Florence), on September 15, 2026, before Judge Joseph Dawson III. Carlsmed is a Nasdaq-listed medical-technology company focused on AI-enabled personalized spine surgery through its aprevo Technology Platform and myaprevo Application. DeGen is a South Carolina spine-implant company based in Florence.
Patents and accused products
The complaint asserts eight Carlsmed patents: U.S. Patents 11,678,938 (at least claim 1); 12,251,320 (at least claim 13); 12,491,085 (at least claims 1 and 11); 12,622,785 (at least claims 24 and 32); 12,636,163 (at least claims 27 and 33); 12,678,228 (at least claims 34 and 38); 12,708,517 (at least claims 1, 10, and 19); and 12,734,040 (at least claims 15, 23, and 31). Carlsmed points the suit at DeGen's custom-designed Solar PS implants and Impulse PS implants, which it says compete with aprevo products and services. Carlsmed seeks a preliminary and permanent injunction, damages (including lost profits and no less than a reasonable royalty), increased damages, and attorneys' fees.
What the patents cover
The asserted claims span computer-based surgical planning and implant design, as well as patient-specific implants and inserter structures. The summaries below identify selected recited features; each asserted claim must be considered as a whole.
U.S. Patent 11,678,938 (Patient-specific medical systems, devices, and methods) describes using patient data and reference datasets associated with treatment outcomes to plan procedures and medical devices. Asserted claim 1 concerns a computer method that builds native and corrected virtual spine models and determines spine metrics. It also requires transmitting a surgical plan to a surgeon, receiving the surgeon's approval, and then designing a patient-specific implant from the approved plan.
U.S. Patent 12,251,320 (Systems and methods for orthopedic implant fixation) covers a personalized fixation system with planning software that adjusts anatomy, plus a non-planar plate shaped at least partly by that planning tool and made to accept bone anchors. Asserted claims: at least claim 13. Claim 13 covers a computer method that models spinal anatomy, accepts a user's proposed changes to the spatial relationship between vertebrae, adjusts the model, measures parameters such as pelvic tilt, sagittal alignment, or lumbar lordosis, and designs one or more patient-specific spinal implants after approval of those measurements.
U.S. Patent 12,491,085 (Systems and methods for orthopedic implant fixation) covers an interbody implant with bone-contacting surfaces, a recess holding a tooth, a deployable tooth for fixation, a break-away bridge that sets a first tooth position, and a lock for a second position. Asserted claims: at least claims 1 and 11. Claim 1 covers a computer method that builds an adjustable 3D spine model, takes user adjustments for patient-specific corrections, maps the negative space between vertebral endplates (including patient-specific contouring), and designs a patient-specific implant system that delivers those corrections when implanted. Claim 11 covers a related method that non-invasively sets a patient-specific correction by adjusting a virtual spine model, maps the corrected negative space between endplates, and designs a patient-specific interbody implant system from that model. Both claims also require designing an implant base with two patient-contoured faces and a deployable fixation element.
U.S. Patent 12,622,785 (Systems and methods for orthopedic implants) covers a manufacturing method that segments anatomy in an image, isolates anatomic elements, manipulates their spatial relationships, maps negative space before and/or after that manipulation, and fills at least part of that space with a virtual implant used to design and make a physical implant. Asserted claims: at least claims 24 and 32. Claim 24 covers a method that receives a patient image, generates a virtual spine model, manipulates vertebral spatial relationships into a corrected model, places a virtual orthopedic implant in the negative space, and sends a plan a user can view on a device. Claim 32 covers a method that receives an image, builds a virtual spine model, determines spatial relationships that represent an anatomical correction, and designs an implant with upper and lower regions matched to the facing vertebrae and a height that spaces them to achieve the correction. Claim 32 also requires causing display of the corrected model and metrics, or of the orthopedic implant.
U.S. Patents 12,636,163 and 12,734,040 (Patient-specific spinal fusion devices and associated systems and methods). Asserted claims of the '163 patent include claims 27 and 33. Claim 27 recites a patient-specific unitary spacer with superior and inferior faces, an anterior face, an anchor channel with a continuous lumen and a contoured exit region, a fixation element, and dense load-bearing and lattice portions. Claim 33 recites a related spacer with a contoured first endplate-facing surface surrounding an aperture, an anterior aperture connected by an anchor channel, and dense load-bearing and lattice portions. Asserted claims of the '040 patent include claims 15, 23, and 31. Their selected features include patient-contoured endplate regions, lattice regions, struts, graft openings, and anchor-receiving structures; the combination varies by claim.
U.S. Patent 12,678,228 (Patient-specific anterior plate implants). Asserted claims include claims 34 and 38. Claim 34 recites a patient-specific cage and an anterior positioning structure with vertebral contact regions and an intermediate projection that contacts the cage; it also specifies projection dimensions and patient-specific contouring. Claim 38 recites a related system with an intermediate projection releasably couplable to the cage and a specified position relative to the vertebrae's anterior margin.
U.S. Patent 12,708,517 (Systems and methods for orthopedic implants). Asserted claims: at least claims 1, 10, and 19. Claim 1 covers a method that receives a patient image, builds a computer spine model, determines spatial relationships for a correction, designs a patient-specific implant with patient-specific endplates, a graft chamber, sidewall lattice and solid regions, and manufactures the implant. Claims 10 and 19 cover anti-subsidence implant systems with patient-specific endplate topography, lattice regions, and solid edge or strut features meant to resist sinking into bone.
What the lawsuit is about
Carlsmed frames this as an operating-company dispute over personalized spine fusion technology. It describes aprevo planning software that models spinopelvic parameters and designs patient-specific interbody implants, and it alleges DeGen offers competing custom Solar PS and Impulse PS implants. The complaint alleges willful infringement as to all patents except the newly issued '040 patent, which Carlsmed says was not part of the pre-suit notice set. Claim charts attached to the complaint walk through DeGen marketing, surgical-technique materials, and presentation slides as evidence for each asserted claim element.
What it means
This is a South Carolina medtech fight between two companies in the patient-specific spine-implant lane. The claim set mixes planning software methods with physical implant and inserter structures, so the case may turn on both how DeGen designs custom cages and what those cages and instruments look like when sold. Carlsmed asks for an injunction as well as money damages, which signals it wants marketplace relief, not only a royalty.
What to watch next
Watch for service and DeGen's answer or early motions. Watch whether Carlsmed seeks a preliminary injunction on the Solar PS or Impulse PS lines. Also watch for claim-construction disputes that separate the planning-method patents from the implant-structure patents, and for any invalidity or prior-art themes DeGen raises once it responds.