510(k) · Cleared
ClearedAcromed Pedicle Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acromed Corp. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 14, 1996 as substantially equivalent to K951116 (Acromed Corp., 1995) after a 63-day review. Its family tree reaches back 1 generation to 1995. 414 later devices descend from it.
- Decided
- Nov 14, 1996
- Review
- 63 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951116 (1995). 414 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- This deviceK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- Descendant · cites it directly · 413 of its ownK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- Descendant · 2 generations on · 410 of its ownK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- Descendant · 3 generations on · 180 of its ownK071890 Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
- Descendant · 4 generations on · 168 of its ownK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
Showing 5 of 414 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 414 · See all- K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998 · cites it directly413descendants
- K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003 · 2 generations on410descendants
- K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · 3 generations on180descendants
- K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009 · 4 generations on170descendants
- K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010 · 4 generations on168descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| 0 (this device) | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| +1 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| +2 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| +3 | K071890 | Zodiac 4.0 Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2007 | 1 |
| +4 | K093077 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2009 | — |
| +4 | K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 9 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 11 | 0 |
| 2013 | 18 | 0 |
| 2014 | 19 | 0 |
| 2015 | 22 | 0 |
| 2016 | 20 | 0 |
| 2017 | 23 | 0 |
| 2018 | 28 | 0 |
| 2019 | 19 | 0 |
| 2020 | 23 | 0 |
| 2021 | 19 | 0 |
| 2022 | 27 | 0 |
| 2023 | 41 | 0 |
| 2024 | 39 | 0 |
| 2025 | 37 | 0 |
| 2026 | 28 | 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 KWP? 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? (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 |
|---|---|---|---|
| * | K951116 | Acromed Pedicle ScrewSummary page 2…with previously cleared components. SUBSTANTIAL EQUIVALENCE: The AcroMed 4.75 mm diameter pedicle screw is equivalent to other AcroMed pedicle screws as cleared under K951116. 2 /S "4 BISD oy ' HA0Z:C 9pRT & Aoy | 1995 |
What descends from it? (414)
See all 4141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982511 | Depuy Motech Moss Miami Spinal Systems | 1998 | 413 |
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 KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AcroMed Pedicle Screw is designed to be utilized with the ISOLA Spine System (K944737). The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. The ISOLA Spinal System, when not used with pedicle screws, is intended hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The…
Read the full statement (186 words)
The AcroMed Pedicle Screw is designed to be utilized with the ISOLA Spine System (K944737). The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained.
The ISOLA Spinal System, when not used with pedicle screws, is intended hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-81.
The component that is the subject of this premarket notification, the 4.75 mm diameter pedicle screw, is a line extension version of AcroMed Pedicle Screws previously cleared under K951657 for the ISOLA system. It is intended for use in pediatric and other applications where anatomic considerations limit the size of the implants that can be used for internal fixation applications.
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/K963639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963639: Acromed Pedicle Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963639
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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