510(k) Report

510(k) · Cleared

Cleared

Biopro Glenoid Component W/ Keel & W/ Posts

K001046510(k) TraditionalCleared Jun 8, 200069-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biopro, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Jun 8, 2000 after a 69-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.

Decided
Jun 8, 2000
Review
69 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2015: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK001046 Biopro Glenoid Component W/ Keel & W/ PostsBiopro, Inc. · 2000
  2. Descendant · cites it directly · 8 of its ownK092474 Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc. · 2010
  3. Descendant · 2 generations on · 6 of its ownK152281 Pyrenees Cervical Plate SystemK2m · 2015
  4. Descendant · 3 generations on · 5 of its ownK172104 Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
  5. Descendant · 4 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
  6. Descendant · 4 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2010: 12015: 22017: 12018: 12022: 12023: 12024: 12026: 1
2010high 2 (2015) · low 0 (2011)2026

Most influential descendants

Showing 5 of 9 · See all
  • K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc. · 2010 · cites it directly8descendants
  • K152281Pyrenees Cervical Plate SystemK2m · 2015 · 2 generations on6descendants
  • K172104Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017 · 3 generations on5descendants
  • K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · 4 generations on4descendants
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001046Biopro Glenoid Component W/ Keel & W/ PostsBiopro, Inc.2000—
+1K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.2010—
+2K152281Pyrenees Cervical Plate SystemK2m2015—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.2017—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK…K2m, Inc.2018—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal…Stryker Spine2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201520
201710
201810
202210
202310
202410
202610
FIG. 1 — Lineage of K001046, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWS? 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 KWS device

  1. #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108

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, K092474 (K2m, Inc., 2010) has gone furthest, with 8 descendants of its own.

How does its category compare?

All KWS devices

KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWS

3in 2025

2007: 22008: 42009: 42010: 72011: 112012: 72013: 122014: 72015: 82016: 102017: 72018: 42019: 92020: 32021: 52022: 52023: 42024: 22025: 32026 (partial year): 2
2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2008: 37 days median2009: 108 days median2010: 33 days median2011: 90 days median2012: 86 days median2013: 120 days median2014: 89 days median2015: 129 days median2016: 114 days median2017: 120 days median2018: 152 days median2019: 106 days median2020: 98 days median2021: 151 days median2022: 158 days median2023: 250 days median2025: 97 days median
2007high 250 (2023) · low 33 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWS

2in 2023

2007: 212008: 292010: 102011: 112012: 102014: 12016: 12017: 42018: 12019: 22020: 52023: 22026 (partial year): 1
2007high 29 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWS

2,281in 2025

2007: 1582008: 2382009: 2942010: 3932011: 4862012: 5422013: 8182014: 1,0662015: 1,1702016: 9702017: 1,6812018: 1,5452019: 1,7282020: 1,5672021: 1,3582022: 1,2682023: 1,7502024: 2,1222025: 2,281
2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—21158
200843729238
200941080294
201073310393
2011119011486
201278610542
2013121200818
201478911,066
2015812901,170
2016101141970
2017712041,681
2018415211,545
2019910621,728
202039851,567
2021515101,358
2022515801,268
2023425021,750
20242—02,122
202539702,281
20262—1—

More from Biopro, Inc.

41 FDA decisions under this applicant name. See the company

  • K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc. · 2017
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017
  • K132510Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013
  • K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
  • K121973Biopro Hemi-Edge Toe SystemBiopro, Inc. · 2012

Recent decisions in KWS

The KWS category page

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
  • K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  • K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A. · 2025

https://510kreport.com/device/K001046 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001046: Biopro Glenoid Component W/ Keel & W/ Posts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001046

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026