510(k) · Cleared
ClearedOsteomark
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ostex Intl., Inc. · JMM Column Chromatography & Color Development, Hydroxyproline
Cleared on Mar 6, 1998 after a 49-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Mar 6, 1998
- Review
- 49 days
- Class
- Class I
- Product code
- JMM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK980518 OsteomarkOstex Intl., Inc. · 1998
- Descendant · cites it directly · 0 of its ownK983674 Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K983674Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX ControlsOrtho-Clinical Diagnostics, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980518 | Osteomark | Ostex Intl., Inc. | 1998 | — |
| +1 | K983674 | Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX… | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 JMM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K983674 | Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX Controls | 1999 | 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?
- Of its descendants, K983674 (Ortho-Clinical Diagnostics, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JMM devicesJMM Column Chromatography & Color Development, Hydroxyproline: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JMM
FDA has decided no JMM device since 2007.
Median 510(k) review, days · JMM
Too few JMM 510(k)s in any year since 2007 to give a median.
Recalls per year · JMM
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JMM
1in 2025
MAUDE reports naming product code JMM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Osteomark is a urinary assay that provides a quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption. Elevated levels of urinary NTx indicate elevated human bone resorption. Measurement of NTx is intended for use in: A. Predicting skeletal response (bone mineral density) to hormonal anti-resorptive therapy in postmenopausal women B. Therapeutic monitoring of: 1. antiresorptive…
Read the full statement (134 words)
Osteomark is a urinary assay that provides a quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption. Elevated levels of urinary NTx indicate elevated human bone resorption. Measurement of NTx is intended for use in:
A. Predicting skeletal response (bone mineral density) to hormonal anti-resorptive therapy in postmenopausal women
B. Therapeutic monitoring of:
1. antiresorptive therapies in postmenopausal women
2. antiresorptive therapies in individuals diagnosed with osteoporosis
3. antiresorptive therapies in individuals diagnosed with Paget’s disease of bone
4. estrogen-suppressing therapies
C. Identifying the probability for a decrease in bone mineral density after one year in postmenopausal women receiving calcium supplement relative to those treated with hormonal antiresorptive therapy.
The measurement range of Osteomark is 20 to 3000 nM Bone Collagen Equivalents (BCE).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980518 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980518: Osteomark.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980518
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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