Develops, manufactures and distributes sterile implants and instruments for spine as well as hand and foot surgery.
Z-Medical GmbH + Co. KG
Tuttlingen (DE) · Atlanta, GA (US)New on Amplifa
Company
Z-Medical GmbH + Co. KG is a privately managed medical technology company based in Tuttlingen. The company develops, manufactures and distributes implants and surgical instruments for spinal surgery (MIS and SZ pedicle screw systems) as well as for hand and foot surgery (Z-Staples). The products are based on in-house developments, meet international standards and are patented internationally. Manufacturing is carried out using high-tech CNC technology; product development uses CAD software including FEM simulation and product testing. Implant assembly takes place under controlled conditions; all implants are individually sterile-packed and are ready for surgery immediately. Quality-relevant production processes are validated and performed in-house. Distribution is via distribution partners worldwide as well as direct sales in Germany; a subsidiary, Z-Medical LP, is located in Atlanta, USA. Customers are hospitals and ambulatory surgery centers in Europe, the USA and other countries.
- Site
- Tuttlingen
- Processes
- CNC manufacturing of implants and surgical instruments (high-tech CNC technology), Implant assembly under controlled conditions, Product development with CAD software including FEM simulation and product testing, Sterile individual packaging of implants and instruments (manufacture in connection with, Manufacture of spinal implants (pedicle screw systems: polyaxial, quattroaxial,, Manufacture of hand & foot implants (Z-Staples in MINI and MEDIUM sizes), Development (CAD, FEM simulation), Own production / manufacturing with high-tech CNC technology
- Materials
- CNC manufacturing, CAD/FEM simulation, Sterile individual packaging
- Certificates
- EN ISO 13485, EC Certificate (Directive 93/42/EEC, Annex II, Notified Body 0297), MDR Certificate (EU 2017/745, Annex IX, QMS), FDA 510(k) clearance MIS Z-Pedicle Screw System, FDA 510(k) clearance Hand & Foot, EWG 93/42 approval MIS Z-Pedicle Screw System, EWG 93/42 approval SZ Pedicle Screw System, EWG 93/42 approval Hand & Foot, EU MDR Certificate 2017/745 Annex IX (490224 MDR2017Q), FDA 510(k) clearances, CE marking (Notified Body 0297), ISO 9001, IATF 16949
- Founded
- 2010
- Industries
- Medical technology, Spinal surgery, Traumatology, Hand and foot surgery, Hospitals and ambulatory surgery centers, Orthopedic surgery (spinal surgery)
- 01
Development (CAD, FEM simulation, product testing)
- 02
CNC manufacturing of implants and surgical instruments
- 03
Implant assembly under controlled conditions
- 04
Quality control
- 05
Sterile individual packaging / sterilization
- 06
Sterile goods warehouse
- 07
Distribution via distribution partners and direct sales
Processes & Manufacturing
CNC manufacturing
Implants and instruments are manufactured using high-tech CNC technology.
CAD/FEM simulation
Product development and product testing with state-of-the-art CAD software including FEM simulation.
Sterile individual packaging
Manufacture in connection with sterilization and maintenance of sterility for class I(s) products.
Locations
Tuttlingen
DEHeadquarters, production, sterile goods warehouse
- High-tech CNC technology
Atlanta
USSubsidiary Z-Medical LP, sales
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| CNC manufacturing of implants and surgical instruments (high-tech CNC technology)Machining | – | – | – | – | – |
| Implant assembly under controlled conditionsAssembly | – | – | – | – | – |
| Product development with CAD software including FEM simulation and product testingEngineering | – | – | – | – | – |
| Sterile individual packaging of implants and instruments (manufacture in connection withSurface | – | – | – | – | – |
| Manufacture of spinal implants (pedicle screw systems: polyaxial, quattroaxial,Assembly | – | – | – | – | – |
| Manufacture of hand & foot implants (Z-Staples in MINI and MEDIUM sizes)Assembly | – | – | – | – | – |
Additional services
Reference customers
Quality & Certificates
Quality-relevant production processes are validated and performed in-house; the QM system is certified according to EN ISO 13485 and is notified-body-monitored under EU MDR (Annex IX). Continuous quality controls, the latest manufacturing methods with CNC technology and FDA 510(k) clearances for the main systems ensure product quality.
| Evidence | Tuttlingen |
|---|---|
| EN ISO 13485 | |
| EU MDR Certificate 2017/745 Annex IX (490224 MDR2017Q) | |
| FDA 510(k) clearances | |
| CE marking (Notified Body 0297) | |
| ISO 9001 | |
| IATF 16949 |
History
- 2010
Company founded, ISO 13485 certification
- 2011
Establishment of sterile goods warehouse, EWG 93/42 approval for hand & foot
- 2013
Start of own production, EWG 93/42 approval for MIS Z-Pedicle Screw System
- 2015
Start of direct sales in Germany, founding of the subsidiary Z-Medical LP in Atlanta/USA, 510(k) clearance for MIS Z-Pedicle Screw System
- 2016
Establishment of a distribution network in Europe and the USA, purchasing agreement with HealthTrust Purchasing Group, L.P.
- 2017
In-house manufacturing for most key production processes, EWG 93/42 approval for SZ Pedicle Screw System
- 2018
Expansion of the distribution network in Europe and worldwide