Evidence map›Paper›PMID 42292495›Full record

ArticleFrontiers in medical technology2026

Effectiveness of electropolishing step on elimination of upstream manufacturing material residues on metallic orthopaedic medical device.

Karolina Godlewska, Christopher Joseph Graham, Michael Frohbergh, Srivaths Kalyan, Rasagnya Viswanadha, Philippe Hasgall

Abstract read
In one paragraph

Article in Frontiers in medical technology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Karolina GodlewskaZimmer Switzerland Manufacturing GmbH, Winterthur, Switzerland.
Christopher Joseph GrahamZimmer, Inc., Warsaw, IN, United States.
Michael FrohberghExponent Inc., Menlo Park, CA, United States.
Srivaths KalyanExponent Inc., Menlo Park, CA, United States.
Rasagnya ViswanadhaZimmer, Inc., Warsaw, IN, United States.
Philippe HasgallZimmer Switzerland Manufacturing GmbH, Winterthur, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Orthopaedic medical device manufacturing often utilizes manufacturing materials or processing aids that can remain on device surfaces as residues and result in leachable chemicals to which patients can be exposed upon contact with the device. Manufacturing steps that modify a device surface through electrochemical means such as electropolishing can remove manufacturing material residues and be considered as surface "reset" in the manufacturing process. In this report, a retrospective analysis of chemical characterization data gathered for medical devices subjected to electropolishing steps during the manufacturing process is summarized. Review of the extractables data from metallic medical devices demonstrated that electropolishing operations effectively remove the residues originating from manufacturing materials utilized upstream of electropolishing. Based on this retrospective review, electropolishing can serve as a surface "reset" point in the manufacturing process in biological safety evaluations, thereby reducing the overall testing requirements, including animal testing, in alignment with the ISO 10993 framework.

Indexed as

biocompatibilitybiological assessmentelectropolishingmanufacturing materials residuesreset

Identifiers

PMID42292495
PMCPMC13253740

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.