One global strategy. Nine jurisdictions.
Our regulatory strategy is built around the principles of doing each market properly, in the right sequence, with the strongest evidence base. We work with leading Notified Bodies and Approved Bodies in each jurisdiction.
Regulatory status by jurisdiction.
China — NMPA
Granted国械注准 20263130176 — Class III. Skull Reconstruction System (DLZ04, DLZ05). Active commercial sales.
European Union — CE-MDR
In progressClass III, Rule 8 (MDR 2017/745). Target Notified Body: TÜV SÜD / DEKRA. Clinical evidence dossier in preparation.
United States — FDA 510(k)
In scopingLikely Class II, 21 CFR 882.5320 (GWO) or equivalent. Pre-submission engagement with FDA CDRH in planning.
United Kingdom — UKCA
In scopingClass III UKCA. Target Approved Body: UL / BSI. Aligned with CE-MDR pathway.
Australia — TGA
In scopingClass III ARTG. TGA conformity assessment. Will leverage MDSAP audit.
Brazil — ANVISA
In scopingClass III ANVISA registration. Will leverage MDSAP audit.
Canada — Health Canada
In scopingClass III Medical Device Licence. Will leverage MDSAP audit.
Japan — PMDA
In scopingClass III pre-market approval. Will leverage MDSAP audit.
Health technology assessment by country.
Different countries have different HTA pathways. We support each one with country-specific evidence dossiers.
United States
- CPT 21184 (cranioplasty) — Medicare 2026 fee ~USD 1,257.51
- Hospital ASP (titanium PSI): USD 5,000 – 8,000 list; GPO USD 3,500 – 5,500
- Hospital ASP (PEEK PSI): USD 15,000 – 25,000 list; GPO USD 10,000 – 15,000
- Coverage: generally covered as medically necessary; prior auth varies by payer
Germany
- OPS-301 5-025.3 (alloplastic cranioplasty)
- DRG B21Z / B22A / B22B
- G-BA / IQWiG standard pathway
- Hospital ASP (titanium PSI): EUR 3,000 – 6,000 list
- Hospital ASP (PEEK PSI): EUR 8,000 – 15,000 list
- GPOs: Prospitalia, AGKAMED, Charité CFM GmbH
France
- LPP Titre III
- HAS / CNEDiMTS assessment
- CCAM procedure coding
- GPOs: UGAP, Resah, UniHA
- Academic centres: AP-HP, Hospices Civils de Lyon, CHU Bordeaux, Toulouse, Marseille
Italy
- CND Y030399 (custom-made cranial implants)
- GPO: Consip
- Academic centres: Niguarda, San Raffaele, Humanitas, Policlinico Gemelli
United Kingdom
- OPCS-4 V03.1 / V03.2 (cranioplasty)
- NPC ABA919 (NHS National Product Catalogue)
- NHS Supply Chain HCTED framework
- Academic centres: Addenbrooke's, King's College, Queen's Square (UCL), Oxford, Edinburgh, Glasgow, Manchester
China
- NMPA Class III — 国械注准 20263130176
- Hospital ASP (titanium PSI): RMB 15,000 – 30,000
- Hospital ASP (PEEK PSI): RMB 50,000 – 150,000
- Provincial VBP risk: CMF not yet covered but 2027–2028 risk
- Major hospitals: Beijing Tiantan, Huashan, Xuanwu, FMMU, Southern Medical, Shenzhen Second People's
How our products are coded.
| Coding system | Code | Note |
|---|---|---|
| GMDN | 61439 / 66699 (legacy) | Transitioning to EMDN in EU |
| EMDN | P04029901 (custom-made CMF implants) | Mandatory in EU from 2026-05-26 |
| CND (Italy) | Y030399 (Impianti cranici specifici paziente) | Italian national classification |
| BASIC UDI-DI | CRANIO-PSI-3D-PEKK-FAM (proposed) | Per implant family, per MDR |
| NPC (UK NHS) | ABA919 (custom-made cranial implants) | NHS National Product Catalogue |
| ICD-10-PCS | 0NR00JZ (replacement of skull with synthetic substitute, open) | US inpatient procedure code |