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Of the major players in the orthopaedic industry, Arthrex and Smith & Nephew continue to dominate the arthroscopy and soft tissue repair market globally. A handful of smaller players, though, entered the segment in the last year with innovative products of which any competitor in the field should be aware.
Here, we present highlights from a variety of technologies cleared and launched during 2014 and 2015 across traditional and biologic approaches.
Traditional Soft Tissue Repair
Growth in the space will continue to arise from knotless fixation techniques, “all-inside” ACL reconstruction, procedure-specific fasteners, hip and knee arthroscopy that attracts young patients and the development of new procedures to reattach torn ligaments and tendons.
Regulatory Highlights:
Arthrosurface
KISSloc Knotless Suture System, FDA 510(k) K133835
• Two low-profile plates + self-cinching suture to correct Hallux Valgus by reducing the intramedullary angle between
1st and 2nd metatarsal bones
• Company expanding from its HemiCap resurfacing technology with hammertoe repair, bunion correction, etc.
MedShape
ExoShape® Femoral Soft Tissue Fastener, FDA 510(k) K132783
• Reportedly the only all-PEEK device that offers non-rotational aperture soft tissue graft fixation on both femoral and
tibial sides to support complete anatomic ACL reconstruction
Morphix® SP Suture Anchor, FDA 510(k) K130467
• Features Scoria™ PEEK material manufactured with interconnected micrometer scale surface porosity; seamless
structure maintains shear strength 2x that of trabecular bone
MTP Solutions
Titanium Suture Anchor, FDA 510(k) K133229
• 1st 510(k)-cleared product; added 3 more in 2014
• Portfolio company of incubator Venture MD
PONTiS Orthopaedics
ferroFIBRE Stainless Steel Suture/Suture Anchor with Crimp, FDA 510(k) K140127
• 1st 510(k)-cleared product under PONTiS name (ferroFIBRE previously cleared under Core Essence)
• Company has developed the Flexor tendon repair system employing suture-crimp system to support a fast,
knotless connection
Valeris Medical
Apollo Suture Anchor System and Titan Screw, FDA 510(k) K142230
• 1st 510(k)-cleared product
• For fixation of ligament, tendon, bone or soft tissue to bone in extremities
• President a former Amendia employee
Product Launches:
Acumed
Scapho-Lunate Inter Carpal (SLIC) Screw
• Features a joint to support rotation between scaphoid and lunate, designed for removal after 6 to 9 months to support
soft tissue repair/allow more time for biological healing
Biomet Sports Medicine
JuggerKnotless Soft Anchor
• All-suture knotless device for labral repair in the shoulder
• 2.1mm drill hole designed to preserve bone, allow more freedom in anchor placement
Cayenne Medical
Quattro® Bolt Tenodesis Screw
• All-arthroscopic approach for tendon-in-socket fixation in upper extremities
SureLock™ All-Suture Anchor system
• Global launch for shoulder and extremities
• Requires smaller pilot hole vs. traditional anchors, minimizing bone removal and decreasing overall anchor footprint
Short SureLock™
• Mini all-suture anchor for small bone indications
DePuy Synthes Mitek Sports Medicine
GRYPHON® Anchors with PROKNOT™ Technology
• Reportedly the 1st arthroscopic hybrid anchor for repair of shoulder and hip instability
• Pre-tied sliding knot forms a construct demonstrated to be up to 41% stronger than tested arthroscopic knots/knotless
devices, up to 64% smaller than standard arthroscopic knots
OrthoPediatrics
Anterior Cruciate Ligament Reconstruction system
• Reportedly the 1st and only system designed for the developing patient
Smith & Nephew
SUTUREFIX™ Ultra soft suture anchor
• Hip and shoulder labral repair
• “Wavelike” design doesn’t rely on bone quality for security
Q-FIX™ All-Suture Anchor
• Hip and shoulder in which anatomic space is limited, such as rotator cuff and labrum repair
• Radially-expanding implant fully deploys at the same depth within bone every time
Biologics for Soft Tissue Repair
Between traditional vs. biologic approaches to repair in 2014, the latter reported more funding activity and larger volume of research activity, specifically in the area of regeneration of ligaments and tendons. Here, we capture recent biologic milestones of note.
Regulatory Highlights:
Anika Therapeutics
MONOVISC®, FDA Premarket Approval
• Reported to be the 1st FDA approved single-injection product with hyaluronate from a non-animal source, for treatment
of knee osteoarthritis pain
Aperion Biologics
Z-Lig™ ACLR, CE Mark Approval
• Reportedly the 1st engineered biologic device for treatment of revision and multi-ligament anterior cruciate ligament
knee reconstruction to receive regulatory approval worldwide
Cytori Therapeutics
• FDA Investigational Device Exemption approval for RECOVER prospective clinical trial of adipose-derived regenerative
cells to treat hamstring injuries
• Will enroll 10 initial patients, followed by expansion to multi-dose, multi-center, double-blind, placebo-controlled trial
Rotation Medical
Collagen Tendon Sheet-DDI, FDA 510(k) K140300
• Expanded clearance to support arthroscopic and mini-open procedures using Collagen Tendon Sheet-DDI for the
management and protection of tendon injuries in which there has been no substantial loss of tendon tissue
Product Launches:
Anika Therapeutics/DePuy Synthes Mitek Sports Medicine
MONOVISC
• 1st U.S. commercial sale
Integra LifeSciences
Integra® Reinforcement Matrix
• Full market launch, porcine dermis biological implant for surgical reconstruction of any type of tendon injury
• Matrix material has been used in >40,000 surgical procedures for >14 years
Orthocell
Ortho-ATI™ tendon repair therapy
• 1st patients treated in Hong Kong
Arthroscopic Equipment
While the large contenders in the soft tissue repair market all sell arthroscopes, visualization equipment, suturing devices and handheld instruments for minimally invasive joint repair, smaller and newer names are entering the arena. During 2014, Tenex Health announced the milestone of 15,000 procedures to treat chronic tendonitis with its TX™ minimally invasive technology to cut and removed damaged tissue in a targeted approach, with ultrasonic image guidance. Other technologies intended to improve processes, costs and outcomes are highlighted below.
Regulatory Highlights:
Integrated Endoscopy
Nuvis Arthroscope, FDA 510(k) K140903
• Reportedly the only single-use rigid endoscope to be commercially available in the U.S.
• 12 molded glass lenses vs. 32-56 expensive ground glass lenses typically used in reusable arthroscopes
• LED technology provides white light at significantly lower temperatures than fiber optic illumination used in
conventional endoscopes
• U.S. launch slated for 3Q15
Trice Medical
mi-eye Camera Enabled Probe, FDA 510(k) K141119
• 1st 510(k) clearance
• Fully disposable single-use device
• Standard 14-gauge needle with integrated camera/light source to perform in-office diagnostic arthroscopy
during initial consultation
Product Launches:
Sawbones/Pacific Research Laboratories
FAST: Fundamentals in Arthroscopy Simulation Training
• Comprises modules designed to increase psychomotor skills required to do successful arthroscopic surgeries
Simbionix
FAST module for ARTHRO Mentor™ virtual reality training simulator
• Modules for shoulder and knee procedures have >70 cases on which to practice skills
ARTHRO Mentor shoulder labral procedure module
• To practice full procedure in various virtual reality cases such as SLAP, Bankart and less common
pathologies such as reverse Bankart
Smith & Nephew
DYONICS™ PLAN Hip Impingement Planning System
• 3D software to generate comprehensive pre-op surgical report for each unique Femoroacetabular impingement
surgical procedure
