510(k) · Cleared
ClearedGMRS Press Fit Stems with Purefix HA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 23, 2003 as substantially equivalent to K022403 (Howmedica Osteonics Corp., 2002) after a 36-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- May 23, 2003
- Review
- 36 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022403 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK022403 GMRS Press Fit Stems with Purefix HAHowmedica Osteonics Corp. · 2002
- This deviceK031217 GMRS Press Fit Stems with Purefix HAHowmedica Osteonics · 2003
- Descendant · cites it directly · 0 of its ownK241716 Global Modular Replacement System, Modular Replacement System…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
Most influential descendants
Showing 1 of 1 · See all- K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022403 | GMRS Press Fit Stems with Purefix HA | Howmedica Osteonics Corp. | 2002 | — |
| 0 (this device) | K031217 | GMRS Press Fit Stems with Purefix HA | Howmedica Osteonics | 2003 | — |
| +1 | K241716 | Global Modular Replacement System, Modular Replacement System, Modular… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022403 | GMRS Press Fit Stems with Purefix HASummary page 1…ar Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFixCQHA Coating were found substantially equivalent in premarket notification K022403. These stems are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFixB HA Coating are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection).…
Read the full statement (126 words)
The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFixB HA Coating are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Press Fit Stems with PureFixB HA Coating.
The 11mm diameter GMRS Press Fit Stems with PureFixB HA will bear a weight limitation on the label. The 11mm stems will be limited to use in patients with a maximum weight of 199 lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031217: GMRS Press Fit Stems with Purefix HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031217
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026