Best-in-class just got better; Smith+Nephew announces 510(k)
clearance of new CATALYSTEM™ Primary Hip System
Engineered for precision, confidence and efficiency in
surgery - and compatible with the CORI◊ Surgical
System
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology
company, today announces it has received 510(k) clearance for its
new CATALYSTEM Primary Hip System from the United States Food and
Drug Administration. The system is designed to address the evolving
demands of primary hip surgery including the increased adoption of
anterior approach procedures and the expanding role of Ambulatory
Surgery Centers (ASCs).
Advancements in primary hip arthroplasty include a shift to a
shorter, proximally filling stem that is easier to prepare and
insert using the direct anterior approach – a less invasive
procedure that may enable improved range-of-motion and faster
recovery for patients.1,2 This segment fits a diverse
range of patient anatomies and is rapidly growing at a compound
annual growth rate >10%.
Building on the heritage of Smith+Nephew’s clinically successful
stem designs,3,4 the CATALYSTEM Primary Hip System was
developed using global data sets across femoral morphologies to
help deliver a precision fit.5,6 Featuring a
triple-taper stem design with uniform proximal loading,7
the reduced distal stem geometry and shorter lengths are ideal for
anterior approach but suitable for all approaches.8
“The design of CATALYSTEM facilitates accurate fit and fill
proximally without distal interference. It is ideally suited for
the direct anterior approach and caters to the diverse needs of my
patients,” said George Haidukewych MD, Orlando Health, Orlando,
Florida and a contributor in the systems design. “Additionally, the
system is delivered in a single modular tray, tailored to my
surgical approach. This helps drive efficiencies in facilitating
more shelf space and reducing sterilization costs - perfect for my
ASC setting.”
The CATALYSTEM Primary Hip System also utilizes proprietary,
patent-pending, ACCUBROACH◊ Technology
delivering proven reproducibility between broach and implant giving
confidence in predictable and reproducible stem
seating.9,10
Don Garbuz, President of the Hip Society, Vancouver, Canada and
a contributor in the systems design said, “We wanted to give
surgeons confidence in broach to implant relationship; the implant
reproducing where the broach was seated. During the design process,
we put in a lot of time developing ACCUBROACH Technology with
various tooth patterns to ensure we could duplicate excellent axial
and rotational stability and validated that the stem sits exactly
where we want it. We’re extremely pleased with the outcome.”
“Building on the strong clinical heritage of POLAR3◊,
our CATALYSTEM Primary Hip System represents a significant
milestone for Smith+Nephew’s hip business, complementing our
current hip portfolio with a primary stem ideal for advanced
anterior approaches, said Craig Gaffin, President Global
Orthopaedics for Smith+Nephew. “Engineered for precision,
confidence and surgical efficiencies, the launch of this new stem
combined with our proprietary, market leading OXINIUM◊
Technology and integration with our robotics platform will help
Smith+Nephew continue to enhance patient outcomes in hip
surgery.”
To learn more about Smith+Nephew’s new CATALYSTEM Primary Hip
System for total hip arthroplasty, please visit
https://www.smith-nephew.com/en/health-care-professionals/products/orthopaedics/catalystem.
- ends –
Enquiries
Media
Dave Snyder +1
(978) 749-1440
Smith+Nephew
References
- Kyriakopoulos G, Poultsides L, Christofilopoulos P. Total hip
arthroplasty through an anterior approach: The pros and cons. EFORT
Open Rev. 2018 Nov 1;3(11):574-583.
- Ang JJM, Onggo JR, Stokes CM, Ambikaipalan A. Comparing direct
anterior approach versus posterior approach or lateral approach in
total hip arthroplasty: a systematic review and meta-analysis. Eur
J Orthop Surg Traumatol. 2023 Oct;33(7):2773-2792
- Smith + Nephew 2024. CATALYSTEM Comparison to legacy stem:
Synergy. Internal Report. 10143364 REV A
- Smith + Nephew 2024. CATALYSTEM Comparison to legacy stem:
POLARSTEM. Internal Report. 10143423 REV A
- Smith + Nephew 2024 CATALYSTEM Summary of Global Evaluations.
Internal Report. 10143591
- Smith + Nephew 2024. Three-dimensional assessment stem fit and
restoration of natural biomechanics in a globally diverse
population of femoral CT scans. Internal Report. TM-24-034
- Smith + Nephew 2024. Finite Element Analysis of the CATALYSTEM
Hip Stem Design. Internal Report. OR-24-025
- Smith + Nephew 2024. Surgeon Feedback on the CATALYSTEM Total
Hip System. Internal Report. CSD.REC.24.001
- Smith + Nephew 2024. Cadaveric study of the repeatability of
CATALYSTEM broach and femoral stem seating level. Internal Report.
10144794
- Smith + Nephew 2024. CATALYSTEM Accubroach Femur to Bone
Interaction Design Rationale. Internal Report. 10142827
This material is provided for informational purposes only
and is not intended to serve as medical advice. It is the
responsibility of operating physicians to determine and utilise the
appropriate products and techniques according to their own clinical
judgment for each of their patients. The clinician
testimonials set out in this material represent the individual
clinician’s own opinions, findings, beliefs, and/or
experiences. Individual results will vary. he
clinicians featured were involved in the development of CATALYSTEM
and were compensated by Smith+Nephew for their
time. To review the information needed to understand
and use CATALYSTEM safely and effectively, including indications
for use, contraindications, effects, precautions, and warnings,
please consult the product’s applicable Instructions for Use (IFU)
prior to use. The information presented in this
material may not be appropriate for all markets. Products featured
may not be available due to regulatory and/or medical practices in
individual markets. Please contact your Smith+Nephew representative
if you have questions about availability of Smith+Nephew products
in your area.
About Smith+Nephew
Smith+Nephew is a portfolio medical technology business focused
on the repair, regeneration and replacement of soft and hard
tissue. We exist to restore people’s bodies and their self-belief
by using technology to take the limits off living. We call this
purpose ‘Life Unlimited’. Our 18,000 employees deliver this mission
every day, making a difference to patients’ lives through the
excellence of our product portfolio, and the invention and
application of new technologies across our three global
business units of Orthopaedics, Sports Medicine & ENT and
Advanced Wound Management.
Founded in Hull, UK, in 1856, we now operate in more than 100
countries, and generated annual sales of $5.5 billion in 2023.
Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN).
The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith
& Nephew plc and its consolidated subsidiaries, unless the
context requires otherwise.
For more information about Smith+Nephew, please visit
www.smith-nephew.com and follow us on X, LinkedIn, Instagram
or Facebook.
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