Manufacturing surgical instruments as an OEM partner – from CAD design and prototyping through robot-assisted series production to approval.
G. Hipp & Sohn GmbH
Neuhausen ob Eck (DE)New on Amplifa
Surgical precision since 1920 – OEM manufacturing made in Germany
Since 1920, G. Hipp & Sohn GmbH has manufactured surgical instruments at its Neuhausen ob Eck site, predominantly as an OEM contract manufacturer for medical technology companies. The product range comprises more than 400 standard and special instruments for MIS and microsurgery, general orthopedics, CMF, thoracic and spine applications, including forceps, distractors, rongeurs, awls, pedicle probes and snap screwdrivers. Products are made from stainless steels, titanium alloys, aluminum and plastics (PPMG, PPSU) with functional and optical coatings; with LUBFREE®, the company offers a lubricant-free instrument system with a diamond-like carbon coating (a-C:H). The Sketch-to-Scale® service supports customers from requirements analysis through CAD design, rapid prototyping (3–6 weeks) and near-series prototypes to robot-assisted series production and MDR/FDA-compliant approval. The QM system is certified to ISO 13485:2016 and compliant with 21 CFR 820; the instruments are used worldwide under customers' labels.
- Site
- Neuhausen ob Eck
- Processes
- CAD design, Rapid prototyping / prototype production (3–6 weeks), Near-series prototypes, Robot-assisted series production of surgical instruments, Manufacturing of surgical instruments (MIS, microsurgery, orthopedics, CMF, thoracic, spine), LUBFREE – lubricant-free instruments with diamond-like carbon coating (a-C:H) and, Functional and optical coatings, Passivation of stainless steel surfaces
- Materials
- Stainless steels, Titanium alloys, Aluminum, PPMG (plastic), PPSU (plastic), Plastic PPMG, Plastic PPSU, Diamond-like carbon coating (LUBFREE®)
- Certificates
- ISO 13485:2016, FDA Listing, ISO 13485, FDA Listing (No. 8010252), 21 CFR 820 compliance
- Founded
- 1920
- Employees
- 40+ (within the
- Industries
- Medical technology, Surgery, Orthopedics, CMF (craniomaxillofacial), Thoracic, Spine
- 01
Feasibility analysis
- 02
Material testing
- 03
CAD design
- 04
Sample production / rapid prototyping
- 05
Near-series prototypes
- 06
Coating (among others LUBFREE®)
- 07
Robot-assisted series production
- 08
Verification & validation
- 09
Approval support (MDR/FDA)
Materials and processes
Stainless steels
Base material of surgical instruments, including passivated surfaces for LUBFREE®.
Titanium alloys
For lightweight, corrosion-resistant surgical instruments and applications close to the implant environment.
Aluminum
Used e.g. in instrument components and housings.
Plastic PPMG
Medical-grade high-performance plastic for instrument components.
Plastic PPSU
Temperature- and sterilization-resistant plastic for instrument components.
Diamond-like carbon coating (LUBFREE®)
Coated friction surface with roughness 0.05 μm; coefficient of friction 0.04 over more than 16,000 cycles, without lubricant.
Site
Neuhausen ob Eck
DEHeadquarters with manufacturing
- Materials
- Stainless steels, titanium alloys, aluminum, plastics (PPMG, PPSU)
- Robot-assisted series production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| CAD designEngineering | – | – | – | – | – |
| Rapid prototyping / prototype production (3–6 weeks)Engineering | – | – | – | – | – |
| Near-series prototypesEngineering | – | – | – | – | – |
| Robot-assisted series production of surgical instrumentsAssembly | – | – | – | – | Stainless steels, Titanium alloys, Aluminum, Plastics PPMG, PPSU |
| Manufacturing of surgical instruments (MIS, microsurgery, orthopedics, CMF, thoracic, spine)Assembly | – | – | – | – | Stainless steels, Titanium alloys, Aluminum, Plastics PPMG, PPSU |
| LUBFREE – lubricant-free instruments with diamond-like carbon coating (a-C:H) andSurface | Roughness 0.05 μm (coefficient of | – | – | – | Stainless steel |
| Functional and optical coatingsSurface | – | – | – | – | Stainless steels, Titanium alloys, Aluminum, Plastics PPMG, PPSU |
| Passivation of stainless steel surfacesSurface | 0.05 μm | – | – | – | Stainless steel |
| Material testingTesting | – | – | – | – | highest-quality materials and alloys |
| Verification & validation / lifetime testing (>16,000 cycles)Testing | – | – | – | – | – |
| Sample productionEngineering | – | – | – | – | – |
| Approval services (MDR documentation, regulatory support)Engineering | – | – | – | – | – |
Additional services
Quality
The quality management system is certified to ISO 13485:2016 (certificate Z241009) and compliant with 21 CFR 820; FDA Listing No. 8010252 is in place. The Digital Traceability Suite (eDHR, UDI Data Matrix, Live QC Dashboard) ensures digital traceability, and all manufacturing processes are validated in accordance with IMDRF guidelines.
| Evidence | Neuhausen ob Eck |
|---|---|
| ISO 13485 | |
| FDA Listing (No. 8010252) | |
| 21 CFR 820 compliance |
History
- 1920
Start of surgical instrument manufacturing made in Germany
- 2020
100+ years of experience in instrument manufacturing