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Biocomposites – Fertigung

Develops and manufactures calcium compounds and specialty polymers for infection management in bone and soft tissue

BI

Biocomposites Ltd.

Keele (UK) · Rostock · Munich · Wilmington, NC (USA) · Shanghai · New Delhi · Buenos Aires · São Paulo · Prato · ChamberetNew on Amplifa

1997Founded (MBO of a ceramics company)
550+Employees in 11 countries
1.4 million units/yearManufacturing capacity (cleanrooms UK, Germany, Argentina)
100+Countries sold in
1 million+Procedures per year using Biocomposites products

About Biocomposites

Biocomposites is an international medical device company headquartered in Keele (Staffordshire, UK) that develops, manufactures and markets products for infection management in bone and soft tissue. The company specializes in innovative calcium compounds and medical specialty polymers for surgical use; the product portfolio includes antibiotic-eluting calcium sulfate carriers (STIMULAN), bone substitute materials based on calcium phosphate and hydroxylapatite (genex, NanoBone), polymer composites (Bilok, Biosteon) as well as bone cement and antibiotic-eluting spacers (SYNICEM). Manufacturing takes place in purpose-built cleanrooms in the UK, Germany and Argentina with a capacity of around 1.4 million units per year; quality assurance, processing, testing and distribution are fully in-house. The products are used in the specialty areas of musculoskeletal infection, orthopedics, traumatology, spine surgery, foot and ankle, podiatry and sports injuries, in over 1 million procedures annually and sold in more than 100 countries. With over 550 employees in 11 countries, Biocomposites maintains subsidiaries including in the USA, China, India, Brazil, Argentina, France, Italy and Germany (Munich, Rostock).

Site
ST5 5NL Keele, Staffordshire
Processes
Manufacturing of calcium compounds and specialty polymer medical devices (engineering, manufactures, Manufacturing in purpose-built cleanrooms (1.4 million units/year), Manufacturing of bone cement and antibiotic-eluting spacers (SYNICEM spacers & bone cement), Manufacturing of bone substitute materials (genex, NanoBone, STIMULAN, Allogran-R, Biosteon), Quality assurance: manufacturing, processing, testing and distribution in-house, Engineering and manufacturing of medical devices (calcium compounds and specialty polymers), Manufacturing in cleanrooms in the UK, Germany and Argentina, In-house quality assurance, processing, testing and distribution
Materials
Calcium sulfate (truly absorbable, recrystallized; STIMULAN), Calcium phosphate composite (osteoconductive, genex), Beta-tricalcium phosphate/calcium sulfate (geneX injectable), Nanocrystalline hydroxylapatite in silica gel matrix (NH-SiO2, NanoBone), Medical polymer composites (specialty polymers, Bilok, Biosteon; carbon fiber reinforced polymer, Acrylic bone cement (SYNICEM bone cement), Calcium sulfate (recrystallized, fully resorbable), Calcium phosphate composite
Certificates
AdvaMed Code of Ethics certification, AdvaMed Code of Ethics, ISO 9001, ISO 13485
Founded
1997
Employees
550+
Industries
Medical technology, Orthopedics, Traumatology, Spine surgery, Foot & ankle surgery, Podiatry
  1. 01

    R&D and product development

  2. 02

    Manufacturing of calcium compounds and specialty polymers in cleanrooms

  3. 03

    Processing and testing (in-house)

  4. 04

    Quality assurance

  5. 05

    Worldwide distribution via own subsidiaries

Materials & Processes

CaSO4

Calcium sulfate (recrystallized, fully resorbable)

Basis of STIMULAN as an antibiotic-eluting carrier for bone and soft tissue infections.

CaP

Calcium phosphate composite

Osteoconductive bone substitute material of the genex product family.

β-TCP/CaSO4

Beta-tricalcium phosphate/calcium sulfate

Injectable bone augmentation in genex for contained defects, among others after curettage of benign bone tumors.

NH-SiO2

Nanocrystalline hydroxylapatite in silica gel matrix

Material of NanoBone, enables neovascularization during bone growth.

PKM

Medical polymer composites (specialty polymers)

Used in Bilok and Biosteon as well as carbon fiber-reinforced polymer cages.

PMMA

Acrylic bone cement

Basis of SYNICEM bone cement and antibiotic-eluting spacers.

Locations

Standort Keele

Keele

GB

Headquarters, cleanroom production, R&D

Lot size
High-volume production (1.4 million units/year total)
Materials
Calcium sulfate, calcium phosphate, polymers, acrylic bone cement
  • Cleanroom manufacturing

Rostock

DE

Site/subsidiary (Biocomposites GmbH, NanoBone/Artoss)

Materials
Nanocrystalline hydroxylapatite in silica gel matrix

Munich

DE

Sales (Biocomposites Deutschland GmbH)

Wilmington, NC

US

Sales (Biocomposites Inc.)

Shanghai

CN

Sales (Biocomposites Shanghai Ltd.)

New Delhi

IN

Sales (Biocomposites India Pvt. Ltd.)

Buenos Aires

AR

Sales/production Subiton Laboratorios (bone cement & spacer)

Materials
Acrylic bone cement

São Paulo

BR

Sales (Biocomposites Ltda.)

Prato

IT

Sales (Biocomposites S.R.L.)

Chamberet

FR

Sales (Synimed)

Products & Components

STIMULAN beads (antibiotic-eluting calcium sulfate beads)
STIMULAN beads (antibiotic-eluting calcium sulfate beads)Calcium sulfate carrier · Musculoskeletal infection
genex injectable bone substitute material
genex injectable bone substitute materialβ-TCP/calcium sulfate · Traumatology
NanoBone SBX
NanoBone SBXHydroxylapatite/silica gel · Spine surgery
NanoBone QD
NanoBone QDHydroxylapatite/silica gel · Orthopedic reconstruction
genex ds putty
genex ds puttyCalcium phosphate composite · Traumatology

Inside the production

Focus on calcium compounds and specialty polymers
Focus on calcium compounds and specialty polymers
Product development at the Keele headquarters
Product development at the Keele headquarters
Quality assurance in manufacturing
Quality assurance in manufacturing
Laboratory
Laboratory
Microscopy in quality inspection
Microscopy in quality inspection
STIMULAN beads in detail
STIMULAN beads in detail

Industries

Medical technologyOrthopedicsTraumatologySpine surgeryFoot & ankle surgeryPodiatrySports injuriesWound and infection managementWound management / infection management in bone and soft tissue

Processes & technical limits

ProcessesToleranceMax. partWeightLot sizeMaterials
Manufacturing of calcium compounds and specialty polymer medical devices (engineering, manufacturesPlastics––––calcium sulfate, calcium phosphate, hydroxylapatite, medical polymers, acrylic bone cement (PMMA)
Manufacturing in purpose-built cleanrooms (1.4 million units/year)Assembly–––1.4 million units per yearcalcium sulfate, calcium phosphate, polymers
Manufacturing of bone cement and antibiotic-eluting spacers (SYNICEM spacers & bone cement)Plastics––––acrylic bone cement
Manufacturing of bone substitute materials (genex, NanoBone, STIMULAN, Allogran-R, Biosteon)Plastics––––calcium sulfate, beta-tricalcium phosphate/calcium sulfate composite, nanocrystalline hydroxylapatite in silica gel matrix, calcium phosphate composite
Quality assurance: manufacturing, processing, testing and distribution in-houseTesting–––––

Additional services

Engineering and manufacturing of medical devices (calcium compounds and specialty polymers)Manufacturing in cleanrooms in the UK, Germany and ArgentinaIn-house quality assurance, processing, testing and distributionR&D with ongoing FDA studies (STIMULAN VG, Phase II)

Quality & Certificates

Quality assurance, processing, testing and distribution are carried out entirely in-house to ensure reliable, predictable and reproducible clinical performance. The processes meet and exceed medical standards along the entire value chain.

EvidenceKeele
AdvaMed Code of Ethics
ISO 9001
ISO 13485

History

  1. 1987

    Founder researched the potential of traditional ceramics in orthopedics

  2. 1997

    Management buy-out of a ceramics company; founding of Biocomposites Ltd., Staffordshire, UK

  3. 1998

    Launch of Bilok and STIMULAN Pellets

  4. 1999

    Launch of FORTOSS and Allogran-R

  5. 2000

    Founding of Biocomposites Inc., Wilmington NC, USA

  6. 2001

    Launch of STIMULAN Kit and Biosteon

  7. 2002

    Launch of genex

  8. 2003

    Founding of Biocomposites (Shanghai) Ltd., China

  9. 2004

    Move to purpose-built headquarters in Keele, Staffordshire

  10. 2007

    Launch of genex putty

  11. 2009

    Launch of genex ds

  12. 2010

    Presence in Canada established

  13. Launch of STIMULAN Rapid Cure

  14. Two Queen's Awards for Enterprise: Innovation and International Trade

  15. Acquisition of Artoss GmbH (NanoBone) and Subiton/SYNIMED (bone cement & spacer)

  16. EU MDR approval for STIMULAN

  17. 2025

    'Most Innovative Product' for STIMULAN at the JWC Awards 2025

  18. 2026

    Biocomposites named in The Sunday Times 100 Tech 2026

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